Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS

January 4, 2019 updated by: Mahmoud Thabet

Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the 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 mid-luteal 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)

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
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35111
        • Recruiting
        • Obstetrics and Gynecology Department in Mansoura University Hospital
        • Contact:
      • Mansourah, Dakahlia, Egypt
        • Recruiting
        • Private practice settings

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

Genders Eligible for Study

Female

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.
  • Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.
  • 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-Prednisolone group
Women will receive clomiphene citrate and prednisolone
Drug: Clomiphene citrate and Prednisolone
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)
Other Names:
  • Clomid and Hostacortin-H
Active Comparator: Clomiphene citrate-placebo group
Women will receive clomiphene citrate and folic acid 0.5mg (placebo)
Drug: Clomiphene citrate and folic acid
Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)
Other Names:
  • Clomid and folic acid

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

Mahmoud Thabet

Investigators

  • Principal Investigator: Mahmoud M Abdelrazik, Dr, Mansoura University
  • Study Director: Mahmoud Thabet, D, 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

February 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 18, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMA1

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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