Clinical Research Directory

Sperm, Exposure and Endocrine Disruptors

The proposed research aims to 1) measure male participants' urinary levels of EDCs and sperm quality before and after report-back and EDC reduction intervention and assess changes, 2) assess the extent to which MM's program (testing, curriculum, and report-back) alters participant environmental health literacy (EHL), readiness to change (RtC), and product/lifestyle choices, and 3) test the feasibility and acceptability of MM's program to male participants. The primary study subjects are adult men of reproductive age. The study aims to have 60 participants complete the study.

Plan A Occlusion and Reversal System Feasibility Study

Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.

Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility

The goal of this observational study is to evaluate whether supplementation with the Ovosicare® Fertility food supplement increases the possibility of becoming pregnant in women aged between 32 and 38 years who have been trying to become pregnant for at least 6 months before starting supplementation.

Fertility Decision and Outcomes in Young Women With Breast Cancer

This observational study is to learn about the fertility outcomes and decision after breast cancer diagnosis, and the current status of fertility consultation and decision support in young women diagnosed with breast cancer in China.

Kegg Fertility Study

Fertility Awareness Based Methods (FABMs), such as calendar tracking, basal body temperature (BBT), and monitoring cervical mucus, are widely used but may have limitations in accurately detecting the complete fertility window. Serum hormone measurements and transvaginal ultrasound are more accurate at determining time of ovulation and fertile window, but are costly and inconvenient. Urine-based luteinizing hormone (LH) tests offer improvement. However, LH surge typically occurs 24 to 36 hours prior to ovulation, only capturing the later portion of the fertile window. A novel approach involves using electrical impedance to track compositional changes in cervical mucus, providing real-time, at-home data. The Kegg device (Lady Technologies Inc, San Francisco, CA, USA) is an intravaginal device that measures cervical mucus impedance to monitor fertility status. Previous studies show it has higher sensitivity, specificity, and accuracy compared to BBT alone in determining the ovulation window. This method offers a cost-effective and practical alternative for at-home fertility tracking. The objectives of this study are to: 1. evaluate the association between Kegg electrical impedance readings and cervical mucus observations with regard to determining fertility status; and 2. compare the accuracy of Kegg electrical impedance readings with hormone urine strips in identifying the complete fertile window determined by cervical mucus observations.

Cycle-to-cycle Variability of Progesterone in the Endometrium in Patients Undergoing an Euploid Blastocyst Transfer in a Hormone Replacement Therapy (HRT) Cycle (PROMICOFET)

This study looks at progesterone, a hormone that prepares the womb lining (endometrium) for pregnancy, in women having a frozen embryo transfer after IVF. Before an embryo is transferred, women take estrogen and progesterone medication to prepare the endometrium. Doctors currently check progesterone levels in the blood, but blood levels do not always match what is happening in the endometrium itself, and it is not yet known whether progesterone levels in the womb tissue stay the same from one treatment cycle to the next. The study also looks at whether hormone levels relate to how the uterus contracts, to the bacteria naturally present in the vagina, cervix, uterus and gut, and to tiny particles released by cells (called extracellular vesicles) that may help the embryo and the womb "communicate" during implantation. Participants are women who are already waiting for genetic test results on their embryos, a wait that typically lasts around 8 weeks. During this time, they go through two practice ("mock") treatment cycles using the same hormone medications as a real embryo transfer, but without an actual embryo. During these cycles, researchers collect blood and urine samples, a small tissue sample from the womb lining, swabs from the vagina, cervix and rectum, and a short ultrasound recording of womb movement. Afterwards, participants proceed with their real embryo transfer cycle, with similar (though fewer) measurements taken, and are followed to see whether they become pregnant. The findings from this study may help doctors better understand how to personalize hormone treatment for future frozen embryo transfers, with the aim of improving pregnancy outcomes.

INtensity of OVarian Stimualtion and Euploid Embryos

This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.

The Weight of Victory: Exploring Short- and Long-term Health Outcomes in Former Male & Female Elite Athletes From Weight-sensitive Sports

The health of former elite athletes has been identified as a critical research gap where there is limited knowledge about both short- and long-term consequences after ending their careers. The transition phase from an active elite career to everyday life has been shown to be particularly problematic, yet this issue has been little studied among former Norwegian elite athletes. Furthermore, questions remain regarding the health of athletes from weight-sensitive sports, such as weight-class, aesthetic, and certain endurance sports. These athletes face specific challenges related to maintaining a certain physique and frequent changes in body weight during their active careers. This group has been shown to be vulnerable to a range of problematic health outcomes related to low energy availability, and little is known about the long-term effects of a career involving this. Therefore, the overall purpose of the project is to map the mental and physical health of former elite athletes. At the same time, there will be a particular focus on the differences between weight-sensitive and less weight-sensitive sports, different types of sports, gender, as well as previous dieting and eating behaviors.

Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy

To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be compared to the ovarian reserve of the patient, previously verified intraoperatively and postoperatively at M6 and M12, these scores being determined according to the vascularization visualized in laparoscopy and established both by a double visual notation (Likert scale) and by a computer software (METAMORPH) objective notation. This procedure would, in patients with fertility disorders or wishing for pregnancy in the short run, reassure them about their reproductive potential immediately after the intervention. In the event of poor staining, if correlated by a decrease in ovarian reserve, the concerned patients could be referred to a MPA treatment facility much earlier in the postoperative period or, if no desire for immediate pregnancy, towards fertility preservation methods.

Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.

A Clinical Trial to Evaluate the Effects of a Supplement on Markers of Female Fertility

This study evaluates the effects of a daily dietary supplement (WeNatal For Her) on markers of female fertility, reproductive health, and sexual health over three menstrual cycles. Forty female participants who are currently trying to conceive will take three capsules of the supplement each morning with their first meal. The study is a single-arm, unblinded hybrid trial. Participants will complete questionnaires at Baseline and on Days 2-5 of Cycles 1, 2, and 3, and will attend a local Labcorp location for blood draws at Baseline and at Cycle 3. Primary outcomes include blood-based biomarkers of female fertility (e.g., AMH, FSH, Estradiol), while secondary outcomes capture self-reported perceptions of reproductive health, energy levels, mood, and overall well-being.

Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM Study)

This study will compare different combinations of fertility signs (cervical mucus (CM), luteinizing hormone \[LH\], pregnanediol glucuronide \[PDG\], and basal body temperature \[BBT\]) to determine which are most reliable for identifying ovulation and luteal phase length. Thirty existing Premom App users will track daily observations for three menstrual cycles. Participants will record mucus, perform urine tests, upload test strip photos to the Premom App, and measure BBT. Both participant readings and AI-assisted app readings will be analyzed. The main goal is to find which marker pairings give the most accurate picture of ovulation timing and luteal phase length. Secondary goals include understanding ease of use, the number of tests required, and whether the app improves accuracy.

Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.

This randomized was designed as non-inferiority trial aiming to compare the number of MII oocytes with 2-shot of Corifollitropin alpha (CFA) sequential administration: 150μg at stimulation day (SD) 1 and 100μg at SD 5 and 1-shot of CFA administration 150μg at SD 1 following by rFSH 200IU daily from SD 8 in women undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.

Exploring and Validating Biomarkers in Menstrual Blood

This study aims to find out whether menstrual blood can provide similar useful biological information to a standard blood sample taken from a vein in the arm as well as uterine biopsies and vaginal swabs. Menstrual and reproductive health have historically been under-represented in research, and menstrual blood remains an under-studied biological sample despite its potential value for understanding women's health. Women aged 18 years and over who are currently menstruating may be invited to take part. Participants will attend a study visit during their menstrual period, where they will provide a menstrual blood sample collected using a menstrual cup and a small blood sample from a vein in the arm.The samples will be sent to a research laboratory and analysed to compare the biological information they contain. Some samples may also be processed to extract DNA and isolate cells for research purposes. The study is low risk and is not expected to provide a direct medical benefit to participants. However, it may help improve understanding of whether menstrual blood could be used more widely in future women's health and fertility research. Participants will not receive individual results, as the tests are for research purposes only and are not designed to provide clinical information about their health.

Outcomes for Patients Who Preserved Their Fertility as Part of Cancer Treatment at the Center for the Study and Preservation of Eggs and Sperm: MaPreservFerti

Improvements in diagnostic methods and cancer treatments have led to a steady increase in survival rates. The 5-year survival rate for men diagnosed with cancer between the ages of 15 and 39 has exceeded 81%. As a result, quality of life-and in particular, addressing the issue of parenthood-has become essential. Cancer treatments-surgery, radiation therapy, and chemotherapy-can significantly impair fertility. They may cause sexual dysfunction (anejaculation, anerection), androgen deficiency, or permanent impairment of spermatogenesis. Yet the desire for parenthood ranks among the top three life goals of patients newly diagnosed with cancer, and 50% of patients wish to have a child in the future. Preserving male fertility is therefore a crucial issue. Before puberty, this can be done by taking a testicular tissue sample, although this is still considered experimental. After puberty, a sample taken from ejaculate allows for the storage of sperm straws. Thus, when a couple wishes to conceive, following a potential reassessment of spermatogenesis if it is impaired, Assisted Reproductive Technology (ART) can be performed with or without the frozen sperm. According to the literature, the sperm is typically used within 10 years of fertility preservation. Little data has been collected regarding whether men with a history of cancer conceive naturally or not. It is therefore important to gather this information regarding fatherhood, particularly whether men with a history of cancer have used ART or not, and whether frozen sperm was used or not, based on the results of the follow-up semen analysis performed after treatment. Primary objective To describe fertility-whether spontaneous or following assisted reproductive technology (ART)-with or without the use of preserved gametes, among patients who underwent fertility preservation for cancer treatment at the CECOS in Lyon between 2010 and 2024. Secondary objective: To assess the population of men who preserved their fertility prior to cancer treatment at the Center for the Study and Preservation of Eggs and Sperm (CECOS) in Lyon between 2010 and 2024, specifically: * The number and clinical and epidemiological characteristics of the patients. * Describe post-cancer fertility * Understand CECOS's care protocols to improve the patient care pathway. * Describe the psychological difficulties at the time of collection that prevented the procedure and thus the preservation of fertility. * Determine the fate of preserved straws that were not used Methodology: * Retrospective analysis of data from the CECOS in Lyon between 2010 and 2024. * Information collected from the database: patient age, indication, type of fertility preservation performed (testicular tissue or ejaculate) * Subsequently, a paper and electronic questionnaire was sent to these same patients to collect data on their fertility following fertility preservation. * Information collected via the questionnaires: marital status, place of residence, paternity prior to cancer, type of cancer, treatment received, achievement of pregnancy after cancer and method (spontaneous pregnancy, reuse of straws at the center, or ART at another center), donation of gametes to research, or destruction if unused. The CECOS in Lyon is an integral part of the Department of Reproductive Medicine and Biology at the Hopsices Civils de Lyon. Population studied: This study focuses on patients with a history of cancer who underwent gonadotoxic treatment and preserved their fertility at the CECOS in Lyon between 2010 and 2024 Inclusion criteria: This study will include patients who: * were between the ages of 18 and 60 at the time of fertility preservation * underwent fertility preservation at the CECOS in Lyon between January 1, 2010, and December 31, 2024. * underwent fertility preservation in the context of cancer treatment * who have indicated their consent to participate in the study by completing the questionnaire Exclusion criteria: * Persons deprived of their liberty by a judicial or administrative decision * Persons receiving psychiatric care * Persons admitted to a health or social care facility for purposes other than research * Adults subject to a legal protection measure (guardianship, conservatorship) Procedure: An information sheet will be sent to patients regarding the analysis of their medical data collected during their care, along with a questionnaire (see attached questionnaire) for the collection of prospective data. The materials will be sent either by mail (with a stamped envelope for free return shipping as part of the study) or electronically via a dedicated and secure CECOS email address for email responses. Number of subjects : 950 Study duration : 1 year Study location : Center for the Study and Preservation of Eggs and Sperm (CECOS)

Lifestyle and Fertility Study on Antioxidant Status, Diet and Early Pregnancy

Researchers believe that certain lifestyle factors can influence a couple's ability to conceive and have a baby. The ISIS Study will look at the health habits of couples who are planning their first pregnancy, and then attempt to measure the effect these habits have on the couple's fertility. The ISIS Study hopes to clarify the link between lifestyle and fertility, and believes that information gained in this project may help future couples in their attempts to conceive.

Fertility Impact of Microplastics - Advancing Countermeasures and Tracking

FERTIMPACT is a prospective clinical study based on the hypothesis that exposure to micro- and nanoplastics (MNPs) is associated with impaired reproductive function. The study will quantify MNPs in human reproductive biospecimens (semen, follicular fluid, endometrial samples, stool and serum) and evaluate their association with clinically relevant fertility parameters, including semen, follicular fluid, and endometrial samples quality, and assisted reproductive technology (ART) outcomes. By integrating biomonitoring with standardized clinical assessment, the study aims to provide robust evidence on exposure-effect relationships in real-world populations undergoing infertility evaluation. This will contribute to improved understanding of environmental determinants of reproductive health and support future risk assessment strategies.

Validation of Donor Oocytes Semi-automated Vitrification

Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011. The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing, a method previously applied. Oocytes reheated after vitrification show excellent results in terms of vitality and recovery of cellular functionality. Indeed, the fertilization rates observed after using warmed and fertilized oocytes in Assisted Reproduction Technology (ART) by intracytoplasmic sperm injection (ICSI) are similar to those obtained with fresh oocytes. However, the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified. Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes. However, manual vitrification requires a learning curve, is technician-dependent and requires significant technical time. A semi-automatic vitrification device (GAVI®, Merck), which recently appeared on the market, has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART. To our knowledge, no study has analyzed the effectiveness of semi-automatic vitrification (GAVI®, Merck) on survival and oocyte quality after warming. It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification. The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device (Gavi) of oocytes with regard to the oocyte survival rate, compared to the manual technique used in ART. The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique, in terms of ART results by comparing the fertilization rates, the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients. This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation. A cost/effectiveness study will be carried out.

New Strategies to Evaluate the Reproductive Tract Microbiome

The goal of this observational study is to evaluate alternative less invasive sampling methods for the analysis of the endometrial microbiome. For that, vaginal swab and endometrial fluid samples will be assessed in comparison with the standard sampling method (an endometrial biopsy), in women aged 18-50 years on an oocyte donation program and/or who attend the clinic for routine gynecological controls, and whose samples will be collected during the secretory phase of a natural menstrual cycle. The study aims to: * Evaluate the pontential of the less invasive techniques to assess the endometrial microbiome, compared to the endometrial biopsy, as well as their safety. * Evaluate the microbiome's stability in a period of 1 to 3 months. Participants will undergo a sampling round (of the 3 sampling methods), and then a second round 1, 2 or 3 months later, as assigned by the investigator.

Developing Resource Interventions for Healthcare Professionals and Patients to Improve Knowledge About Fertility in Primary Ciliary Dyskinesia

This project will involve working with people with PCD and medical professionals to develop resources that will help patients and the people providing their care to better understand fertility and pregnancy safety in people with this condition.

JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China

The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate early-life health trajectories and intergenerational transmission of diseases, health status, and psychological-behavioral patterns. Data collection includes biospecimens (placenta, cord blood, breast milk, blood, urine, feces) and multi-omics analysis (genomic, proteomic, metabolomic, microbiomic), alongside clinical information from preconception, pregnancy, birth through childhood (0-14 years). The cohort covers 24 stratified sites across China, incorporating real-time environmental monitoring (air pollution, meteorological data) and sociogeographic factors. Targeting reproductive-age couples (18-45 years) and their offspring, the study addresses multigenerational health linkages, urban-rural disparities, and regional diversity from 2025 to 2039. By integrating genetic, environmental and lifestyle data, this research will identify critical intervention windows and mechanisms for chronic disease transmission across generations, supporting China's "Healthy China" initiative and developing targeted strategies for population health and aging.

Ablative Technique For Ovarian Preservation In Endometrioma

The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are: How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment? Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications. Participants will: Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period

Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification

Endometrial cancer (EC) stands among the most common gynecological malignancies in developed countries and regions, with a notable trend toward younger age at onset. Correspondingly, the demand for fertility-sparing treatment (FST) has been increasingly prominent among young EC patients. High-potency progestogens remain the sole therapeutic option recommended by international guidelines for this patient population; however, approximately 30% of patients exhibit no response to such treatment. The concept of EC molecular subtyping, proposed by The Cancer Genome Atlas (TCGA) in 2013, has revolutionized the diagnosis and management of EC. EC subtypes with distinct molecular features demonstrate substantial differences in biological behaviors and responses to pharmacotherapeutic interventions. Nevertheless, the role of molecular subtyping in guiding FST decision-making-both in terms of its applicability and specific mechanisms-remains an unmet research need worldwide. Notably, the POLE-mutant and microsatellite instability-high (MSI-H) subtypes display the highest sensitivity to immune checkpoint inhibitors, underscoring the clinical value of exploring their utility in FST. The no specific molecular profile (NSMP) subtype is sensitive to progestogens but lacks reliable predictive biomarkers-accurate pre-treatment prediction would enable tailored treatment selection, shorten treatment duration, and enhance therapeutic outcomes. In contrast, the p53-abnormal (p53abn) subtype is associated with a poor prognosis, and FST is therefore not recommended for this subgroup. Building on the aforementioned background and our research team's preliminary clinical findings, this project focuses on the field of FST for EC. To address the current challenges-including narrow indications, limited treatment options, suboptimal efficacy, and the absence of precise personalized regimens-we aim to conduct the world's first prospective multicenter umbrella trial based on EC molecular subtyping. Optimal novel diagnostic and therapeutic protocols will be developed for each molecular subtype, with the goals of optimizing existing FST strategies, improving FST efficacy and reproductive outcomes, expanding eligible indications, and providing high-quality clinical evidence for molecular subtype-guided FST in EC, thereby advancing the overall effectiveness of FST for EC patients.

Reproductive Prognosis in Women Seeking Offspring After Medical or Surgical Therapy for Endometriosis

The study aims to compare the percentage of women with endometriosis who undergo PMA after medical vs surgical treatment and to describe conception patterns, pregnancy rates, and number of live vessels in women seeking offspring with endometriosis.