Concomitant CC and E2 Versus CC Alone in Ovulation Induction

NCT ID: NCT02186782

Last Updated: 2017-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Infertility Anovulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clomiphene citrate-Estradiol group

Women will receive clomiphene citrate and estradiol

Group Type ACTIVE_COMPARATOR

Clomiphene citrate and Estradiol

Intervention Type DRUG

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 group

Women will receive clomiphene citrate and placebo

Group Type ACTIVE_COMPARATOR

Clomiphene citrate and Placebo

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DRUG

Other Intervention Names

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Clomid and Estradiol valerate Clomid and Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maher elesawi kamel elesawi

OTHER

Sponsor Role lead

Responsible Party

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Maher elesawi kamel elesawi

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed M Badawy, Prof

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Maher E Kamel Elesawi, Dr

Role: STUDY_DIRECTOR

Mansoura University

Mohamed S Abdelhafez, Dr

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Private practice settings

Mīt Ghamr, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maher E Kamel Elesawi, Dr

Role: CONTACT

+201016103662

Ahmed M Badawy, Prof

Role: CONTACT

+201282848485

Facility Contacts

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Ahmed M Badawy, Prof

Role: primary

+201282848485

Maher E Kamel Elesawi, Dr

Role: primary

+20104523494

Other Identifiers

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ME1

Identifier Type: -

Identifier Source: org_study_id

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