Anovulation, Infertility
Conditions
Keywords
Clomiphene citrate, Estradiol, Endometrial thickness
Brief summary
The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.
Detailed description
Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle.
Interventions
DRUGClomiphene citrate and Estradiol
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)
DRUGClomiphene citrate and Placebo
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)
Sponsors
Maher elesawi kamel elesawi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Infertile women with eugonadotrophic anovulation/oligoovulation. * Unexplained infertility.
Exclusion criteria
* Age \< 20 or \> 35 years. * Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2. * Presence of any infertility factor other than anovulation/oligoovulation. * Previous history of ovarian surgery or surgical removal of one ovary. * Previous exposure to cytotoxic drugs or pelvic irradiation. * Metabolic or hormonal abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 6-8 weeks gestational age | Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness on day of HCG administration | 3 months | Endometrial thickness by TVS on day of HCG administration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ovulation rate | 3 months | Number of ovulatory cycles divided by the number of stimulation cycles |
| Number of ovarian follicles ≥ 18 mm on day of HCG administration | 3 months | Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration |
Countries
Egypt
Contacts
Primary ContactMaher E Kamel Elesawi, Dr
Backup ContactAhmed M Badawy, Prof
Outcome results
None listed