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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT02436226 (opens ClinicalTrials.gov in a new tab)Other idMT1
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Overview

Status
Completed
Phase
Phase 4
Enrollment
300 participants (actual)
Sponsor
Mohamed Sayed Abdelhafez · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
Mar 2016
Primary completion
Jan 2023
Completion
Jan 2023
First posted
6 May 2015 (estimated)
Last update posted
31 Oct 2023
Conditions
Infertility · Polycystic Ovarian Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162018202020222024
  1. Ph 4

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

    NCT02436226

    Mar 2016 to Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Clomiphene citrate and Human chorionic gonadotropin (HCG)Drug
  • Clomiphene citrateDrug

Arms2

  • Active comparator

    Clomiphene citrate-HCG group

    Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)

  • Active comparator

    Clomiphene citrate group

    Women will receive clomiphene citrate alone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ovulation rate

    Time frame · 3 months

    Registry description

    Number of ovulatory cycles divided by the number of stimulation cycles

Secondary outcomes(4)

  1. Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation

    Time frame · 3 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Incidence of OHSS within 9 days of final triggering of oocyte maturation

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedThabet M, Abdelhafez MS, Elshamy MR, Albahlol IA, Fayala E, Wageeh A, El-Zayadi AA, Bahgat NA, Mohammed SM, Mohamed AA, Awad MM, El-Menayyer A, El-Sherbiny M, Elsherbini DMA, Albarakati RG, Alshaikh ABA, Edris FE, Bushaqer NJ, Salama YGM, Abdel-Razik MM. Competence of Combined Low Dose of Human Chorionic Gonadotropin (HCG) and Clomiphene Citrate (CC) Versus Continued CC during Ovulation Induction in Women with CC-Resistant Polycystic Ovarian Syndrome: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Aug 12;60(8):1300. doi: 10.3390/medicina60081300. PMID 39202581

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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