Clinical Trials Logo

Clinical Trial Summary

This study will assess the change in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered.


Clinical Trial Description

Late-follicular elevated progesterone (LFEP) following ovarian stimulation for assisted reproductive technologies (ART) has been linked to abnormal endometrial receptivity expression profiles and lower pregnancy rates. For this reason, physicians frequently propose that patients with LFEP avoid performing a fresh embryo transfer, postponing instead it to a subsequent unstimulated cycle. Although this strategy may reduce the detrimental effect LFEP may have on cumulative ART pregnancy rates, it may also frustrate couples who wish to become pregnant as soon as possible. With the intent of minimizing potentially-avoidable treatment delays, an increasing number of researchers are proposing that physicians revisit their current ovarian stimulation regimens. One strategy which may reduce the incidence of LFEP is to decrease the dose of gonadotropins administered at the end of stimulation (i.e. a stepdown protocol). A similar approach, using corifollitropin alpha (CFA), has also been recently advanced, taking advantage of the stepdown-like pharmacodynamic profile of this compound. In order to assess the clinical usefulness of these strategies, the investigators propose a single-center, open-label, paired, randomized trial. The main objective of this study is to assess the changes in the endometrial gene expression profile on the day of fresh embryo transfer according to the type of gonadotropins administered for ovarian stimulation. In summary, all consenting subjects will first undergo an endometrial biopsy seven days after the luteinizing hormone peak in an unmedicated natural cycle. This biopsy will serve as the baseline endometrial biopsy (natural cycle biopsy) for a gene expression analysis. Following this baseline biopsy, subjects will be randomly allocated to a specific type of ovarian stimulation regimen in order to later perform a second endometrial biopsy, this time five days after oocyte retrieval (stimulated cycle biopsy). Subjects will be randomized to administer, on the third day of their menstrual cycle, either a single dose of 150 IU of CFA (study arms 1A and 1B) or a fixed daily dose of 200 or 300 IU of recombinant follicle stimulating (rFSH, study arm 2). On the eighth day of stimulation, it is expected that 15% to 30% of all subjects who performed CFA will have reached the follicular development criteria for final oocyte maturation and ovulation triggering. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03755973
Study type Interventional
Source Instituto Valenciano de Infertilidade de Lisboa
Contact
Status Completed
Phase Phase 4
Start date January 29, 2020
Completion date May 22, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting NCT05358483 - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Completed NCT03177538 - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders Phase 4
Completed NCT03638856 - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy N/A
Completed NCT04052464 - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn NCT04753736 - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC N/A
Completed NCT03349905 - Deferred Versus Fresh Embryo Transfers N/A
Completed NCT05076981 - Progesterone Levels During Ovulation and Luteal Phase
Completed NCT04096027 - Cabergoline Before or After Oocyte Collection for Follicular Resolution Phase 4
Recruiting NCT05980091 - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. Phase 1
Terminated NCT01933633 - Improved Fertility After Exercise in Overweight/Obese Women N/A
Terminated NCT01202643 - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF Phase 1/Phase 2
Completed NCT01202656 - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) Phase 1/Phase 2
Completed NCT01408615 - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation NCT05698550 - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET Phase 3
Not yet recruiting NCT03910582 - Personalized FET in RIF Patients With Displaced Dating N/A
Completed NCT05440019 - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed NCT05130125 - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer