Early Luteal Phase Progesterone Kinetics After hCG-Induced Ovulation in Modified Natural Cycle
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hCG.
- Who it may be relevant to
- Registry conditions: Luteal Phase Insufficiency. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evolution of Luteal Progesteronemia in a Modified Natural Cycle (Ovulation Triggered by hCG): Pilot Study
Overview
This pilot study evaluates how progesterone levels change after hCG-triggered ovulation in modified natural cycles. Forty women preparing for frozen embryo transfer will have blood tests over 6 days to monitor hormone levels. The goal is to understand whether hCG affects the timing of the luteal phase and embryo implantation.
Interventions
- Drug hCG
Subcutaneous injection of 250 µg of recombinant hCG (Ovitrelle®)
Primary outcome measures
- Serum Progesterone Level on Day 3 After hCG Trigger [Time frame: 3 Days After hCG Injection]
Eligibility criteria
Inclusion criteria
- At least 1 follicle of 14 mm or more
- Endometrium of 6 mm or more
- Plasma luteinizing hormone (LH) less than 2 times basal level (measured at the beginning of the cycle between D1 and D4) and progesteronemia less than 1.5 ng/mL
- For whom ovulation induction with recombinant hCG (Ovitrelle) is then proposed (standard care).
Exclusion criteria
- Patient whose venous capital contraindicates repeated blood sampling over a short period of time over a short period.
- Patient treated with exogenous natural progesterone (vaginal or injectable) which may interfere or synthetic progesterone, which may interfere with endogenous progesterone secretion.
- Patient who has not given written consent to participate in the study.
- Patient not fluent in French.
- Patient under guardianship, curators or without social security coverage.
- Patient participating in another study with an ongoing exclusion period or other interventional research with no ongoing exclusion period involves the use of a drug or procedure capable of altering progesterone levels .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Hôpital Arnaud de Villeneuve — Montpellier
Publications
- Mizrachi Y, Horowitz E, Ganer Herman H, Farhi J, Raziel A, Weissman A. Should women receive luteal support following natural cycle frozen embryo transfer? A systematic review and meta-analysis. Hum Reprod Update. 2021 Jun 22;27(4):643-650. doi: 10.1093/humupd/dmab011. PMID 33829269
- Lee VC, Li RH, Chai J, Yeung TW, Yeung WS, Ho PC, Ng EH. Effect of preovulatory progesterone elevation and duration of progesterone elevation on the pregnancy rate of frozen-thawed embryo transfer in natural cycles. Fertil Steril. 2014 May;101(5):1288-93. doi: 10.1016/j.fertnstert.2014.01.040. Epub 2014 Mar 3. PMID 24602752
Identifiers
NCT: NCT07028710 · RECHMPL24_0200