Concomitant CC and E2 Versus CC Alone in Ovulation Induction

March 21, 2017 updated by: Maher elesawi kamel elesawi

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35111
        • Recruiting
        • Obstetrics and Gynecology Department in Mansoura University Hospital
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • Private practice settings
        • Contact:
        • Principal Investigator:
          • Ahmed M Badaway, Prof
      • Mit Ghamr, Dakahlia, Egypt
        • Recruiting
        • Private practice settings
        • Contact:
        • Principal Investigator:
          • Maher E Kamel Elesawi, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clomiphene citrate-Estradiol group
Women will receive clomiphene citrate and estradiol
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)
Other Names:
  • Clomid and Estradiol valerate
Active Comparator: Clomiphene citrate group
Women will receive clomiphene citrate and placebo
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)
Other Names:
  • Clomid and Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 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
6-8 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness on day of HCG administration
Time Frame: 3 months
Endometrial thickness by TVS on day of HCG administration
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation rate
Time Frame: 3 months
Number of ovulatory cycles divided by the number of stimulation cycles
3 months
Number of ovarian follicles ≥ 18 mm on day of HCG administration
Time Frame: 3 months
Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maher elesawi kamel elesawi

Investigators

  • Principal Investigator: Ahmed M Badawy, Prof, Mansoura University
  • Study Director: Maher E Kamel Elesawi, Dr, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

June 28, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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