Effect of Estradiol Pretreatment on Antagonist ICSI Cycles

Phase 4

Completed

• Conditions: Female Infertility
• Interventions: Drug: Estradiol Valerate 4mg

• Registration Number: NCT05197374
• Lead Sponsor: Alexandria University

Brief Summary

Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles

Detailed Description

Gonadotropin-releasing hormone antagonist (GnRH-ant) cycles are characterized by higher patient acceptability with more attention being directed to the potential effect of steroid pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates clinical criteria for human chorionic gonadotropin (hCG) administration. This phenomenon is associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo selection for embryo transfer. Indeed, the large number of available embryos represented an important prognostic factor of invitro-fertilization (IVF) outcome, particularly in poor prognosis patients, possibly by increasing the probability that at least one good-quality embryo will be selected for embryo transfer. During COH, a better understanding of follicular development has resulted in the improvement of strategies for ovarian stimulation. This approach represents a potential and more physiological alternative to GnRH agonist or oral contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and improve controlled ovarian hyperstimulation (COH) results. The present study is a randomized controlled trial that investigated whether E2 pre-treatment during the luteal phase affects developmental characteristics of growing follicles during COH. It depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual FSH elevation that occurs during the late luteal phase, thus testing for detection of the effect of luteal estradiol on follicular synchronization and its effect on ICSI outcome.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-11-15
• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-19
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

1. Women age 20-37 years.
2. Anti-mullerian (AMH) level greater than 1.2 ng/ml.
3. Body mass index between 18 and 29 kg/m2.
4. Undergoing a first or second ICSI cycles.

Exclusion Criteria

1. Endometriosis.
2. Uterine disorders such as fibroids and uterine anomalies.
3. Antral follicular counts (AFC) less than 10.
4. Azoospermic males.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Estradiol Valerate 4mg	Cases who received estradiol pretreatment then underwent ICSI.

Primary Outcome Measures

Name	Time	Method
Serum estradiol and progesterone level on day of hCG .	7-16 days after start of controlled ovarian stimulation.	serum level of estradiol pg/dl and progesterone ng/dl on day of hCG administration
Total number of gonadotropin ampoules used.	7-16 days after start of controlled ovarian stimulation.	number of gonadotropin ampules used from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration
Total number of follicles by U/S on day of hCG.	7-16 days after start of controlled ovarian stimulation.	number of follicles by ultrasound scan on day of hCG administration
Number of good quality embryos.	3 days after oocyte retrieval.	number of grade 1 and grade 2 day 3 embryos
Endometrial thickness on day of hCG.	7-16 days after start of controlled ovarian stimulation.	thickness of endometrium in mm on day of hCG
Days of stimulation.	7-16 days after start of controlled ovarian stimulation.	number of days from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration until day of hCG administration
Number of mature oocytes	36 hours after oocyte retrieval.	number of metaphase II oocytes after denudation

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	2 weeks after positive pregnancy test	The number of clinical pregnancies (defined as the presence of a gestational sac with positive heart beat detected by transvaginal ultrasound scan 2 weeks after positive pregnancy test) divided by the number of embryo transfer procedures
Pregnancy rate	14 days after embryo transfer	the number of positive pregnancies (defined as serum B-hCG more than 5 miu/ml measured 14 days after embryo transfer) divided by the number of embryo transfer procedures.

Trial Locations

Locations (1)

IVF center; 🇪🇬 Alexandria, Egypt