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

Last updated: January 4, 2019
Sponsor: Mahmoud Thabet
Overall Status: Active - Recruiting

Phase

4

Condition

Infertility

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

N/A

Clinical Study ID

NCT02344888
MMA1
  • Ages 20-35
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

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 5consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion

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 Design

Total Participants: 300
Study Start date:
February 01, 2015
Estimated Completion Date:
January 31, 2019

Study 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

Connect with a study center

  • Obstetrics and Gynecology Department in Mansoura University Hospital

    Mansoura, Dakahlia 35111
    Egypt

    Site Not Available

  • Obstetrics and Gynecology Department in Mansoura University Hospital

    Mansourah, Dakahlia 35111
    Egypt

    Active - Recruiting

  • Private practice settings

    Mansourah, Dakahlia
    Egypt

    Active - Recruiting

  • Obstetrics and Gynecology Department in Port Said University

    Port Said,
    Egypt

    Site Not Available

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