Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

October 27, 2023 updated by: Mohamed Sayed Abdelhafez

Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day 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 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 (Actual)

300

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 Locations

  • Egypt
      • Mansourah, Egypt, 35111
        • Obstetrics and Gynecology Department in Mansoura University Hospital

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 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infertile lean women with PCOS as defined by the Rotterdam criteria.
  • CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

  • Age < 20 or > 35 years.
  • Presence of any infertility factor other than anovulatory PCOS.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
  • 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clomiphene citrate-HCG group
Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)
Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)
Other Names:
  • Clomid and Choriomon
Active Comparator: Clomiphene citrate group
Women will receive clomiphene citrate alone
Drug: Clomiphene citrate
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
Other Names:
  • Clomid

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation
Time Frame: 3 months
Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation
3 months
Endometrial thickness on day of triggering of oocyte maturation
Time Frame: 3 months
Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation
3 months
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
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Time Frame: Within 9 days of final triggering of oocyte maturation
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Within 9 days of final triggering of oocyte maturation

Collaborators and Investigators

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

Sponsor

Mohamed Sayed Abdelhafez

Investigators

  • Study Chair: Mohamed S Abdelhafez, MD, Mansoura University
  • Study Director: Maged R Elshamy, MD, Mansoura University
  • Study Director: Mohamed A Elnegery, MD, Mansoura University
  • Principal Investigator: Mahmoud Thabet, MD, Mansoura University
  • Study Director: Khaled S Ismael, MD, Mansoura University
  • Study Director: Ahmed Ragab, MD, Mansoura University
  • Study Director: Hamed Youssef, MD, Mansoura University
  • Study Director: Mahmoud M Abdel-razik, MD, 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 (Actual)

March 1, 2016

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

May 2, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimated)

May 6, 2015

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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