Skip to main content
OpenTrials
Completed

NCT Number: NCT05197374

Effect of Estradiol Pretreatment on Antagonist ICSI Cycles

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IVF center

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Estradiol Valerate 4mg

Drug

Estradiol valerate 2 mg (two tablet once daily) started 5 days before expected menses (or 7 days after ovulation of previous cycle). After start of menses, estradiol pretreatment was stopped and controlled ovarian stimulation started.

Other names: Progynova

Primary outcomes

  1. Days of stimulation.

    Time frame: 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

  2. Total number of gonadotropin ampoules used.

    Time frame: 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

  3. Total number of follicles by U/S on day of hCG.

    Time frame: 7-16 days after start of controlled ovarian stimulation.

    number of follicles by ultrasound scan on day of hCG administration

  4. Serum estradiol and progesterone level on day of hCG .

    Time frame: 7-16 days after start of controlled ovarian stimulation.

    serum level of estradiol pg/dl and progesterone ng/dl on day of hCG administration

  5. Endometrial thickness on day of hCG.

    Time frame: 7-16 days after start of controlled ovarian stimulation.

    thickness of endometrium in mm on day of hCG

  6. Number of mature oocytes

    Time frame: 36 hours after oocyte retrieval.

    number of metaphase II oocytes after denudation

  7. Number of good quality embryos.

    Time frame: 3 days after oocyte retrieval.

    number of grade 1 and grade 2 day 3 embryos

Secondary outcomes

  1. Pregnancy rate

    Time frame: 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.

  2. Clinical pregnancy rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Studying The Effect of Estradiol Pretreatment on Follicular Synchronization and Intracytoplasmic Sperm Injection (ICSI) Outcome in Antagonist Cycles

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.