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Completed

NCT Number: NCT02436226

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

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).

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, 35111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clomiphene citrate and Human chorionic gonadotropin (HCG)

Drug

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

Clomiphene Citrate

Drug

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)

Other names: Clomid

Primary outcomes

  1. Ovulation rate

    Time frame: 3 months

    Number of ovulatory cycles divided by the number of stimulation cycles

Secondary outcomes

  1. 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

  2. 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. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Abdelhafez

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
May 6, 2015
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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