Concomitant CC and E2 Versus CC Alone in Ovulation Induction

Infertility Clinical Trial

Official title:

Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186782
• Other study ID #: ME1
• Status: Recruiting
• Phase: Phase 4
• First received: June 28, 2014
• Last updated: March 21, 2017
• Start date: June 2014
• Est. completion date: August 2018

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: Maher E Kamel Elesawi, Dr
• Phone: +201016103662
• Email: maherelesawi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anovulation
• Infertility

Intervention

Drug:
• Clomiphene 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)
• Clomiphene 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)

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansoura	Dakahlia
Egypt	Private practice settings	Mansoura	Dakahlia
Egypt	Private practice settings	Mit Ghamr	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Maher elesawi kamel elesawi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ovulation rate	Number of ovulatory cycles divided by the number of stimulation cycles	3 months
Other	Number of ovarian follicles = 18 mm on day of HCG administration	Number of ovarian follicles = 18 mm by TVS on day of HCG administration	3 months
Primary	Clinical pregnancy rate	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	6-8 weeks gestational age
Secondary	Endometrial thickness on day of HCG administration	Endometrial thickness by TVS on day of HCG administration	3 months