Clinical Trials Logo

Clinical Trial Summary

One of the indications of freezing is to reduce the risk of ovarian hyperstimulation syndrome particularly in polycystic ovarian disease (PCOS) women. Very few RCTs addressed the issue of optimizing the endometrium for a frozen cycle. Interestingly, Letrozole for ovarian stimulation showed significantly better reproductive outcome when compared with hormone replacement therapy (HRT) cycle. In addition, HRT cycle has been associated with higher miscarriage rate when compared with natural cycle frozen embryo transfer. Nevertheless, there is not yet a well-designed prospective randomized study comparing letrozole and HRT in PCOS women undergoing frozen embryo transfer.


Clinical Trial Description

Freezing oocytes and embryos has become an integral part of the daily IVF practice. One of the indications of freezing is to reduce the risk of ovarian hyperstimulation syndrome particularly in polycystic ovarian disease (PCOS) women. Very few randomized control trials addressed the issue of optimizing the endometrium for a frozen cycle. As PCOS women do not regularly ovulate, most of their frozen cycles are conducted after hormonal replacement therapy (HRT) preparation of the endometrium or after ovulation induction. In HRT cycle the endometrium is prepared using exogenous estradiol and progesterone. While HRT cycles requires less monitoring and easy scheduling, it is costly, associated with increased risk of thrombosis and women must continue using the exogenous hormones up to 10 to 12 weeks of gestation. Interestingly, Letrozole for ovarian stimulation showed significantly better reproductive outcome when compared with HRT cycles. In agreement with the previous Chinese study, a retrospective Japanese ART registry data that included 110 722 frozen cycles confirmed the superiority of letrozole. Nevertheless, there is not yet a well-designed prospective randomized study. In addition, HRT cycle has been associated with higher miscarriage rate when compared with natural cycle frozen embryo transfer. HRT is usually used in patients with PCOS. A retrospective study including 2664 PCOS patients showed significant decrease in the pregnancy loss when letrozole was used when compared with HRT in frozen cycles. Investigators thought of comparing letrozole and HRT in women with PCOS who are undergoing frozen cycles in PCOS women. Live birth and miscarriage rates will be the primary outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05168865
Study type Interventional
Source Dubai Fertility Center
Contact
Status Withdrawn
Phase Phase 4
Start date August 1, 2023
Completion date April 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Enrolling by invitation NCT01689428 - Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases Phase 3
Completed NCT00194844 - Couples Miscarriage Healing Project:Randomized Trial Phase 1/Phase 2
Recruiting NCT05789940 - Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention N/A
Recruiting NCT03628625 - Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage Phase 2
Not yet recruiting NCT05579756 - Psychatric Impact of Miscarriage in Assiut University Hospital
Not yet recruiting NCT05557201 - Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
Not yet recruiting NCT05039853 - Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task N/A
Recruiting NCT01223482 - A Study Looking at Women's Experiences After a Miscarriage N/A
Completed NCT04604366 - Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage Phase 2
Not yet recruiting NCT05088707 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage N/A
Not yet recruiting NCT05103098 - Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage N/A
Not yet recruiting NCT05088720 - Misoprostol for Management of Women With an Incomplete Miscarriage N/A
Not yet recruiting NCT05094375 - Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage N/A
Recruiting NCT05304273 - Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages Phase 3
Not yet recruiting NCT05653414 - Interest of a Short Early Psychological Care in Women With Miscarriage N/A
Recruiting NCT03976544 - Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients Phase 4
Completed NCT01916928 - The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage N/A
Completed NCT03940495 - Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
Completed NCT04512820 - Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study N/A