Female Infertility
Conditions
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.
Interventions
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 37 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of mature oocytes | 36 hours after oocyte retrieval. | number of metaphase II oocytes after denudation |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed