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

NCT02436226 | Completed Phase 4

• 1 other identifier: MT1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Infertility; Polycystic Ovarian Syndrome

Keywords

PCOS; Clomiphene citrate resistant; HCG

Outcome Measures

Primary Outcomes (1)

• Ovulation rate

  Number of ovulatory cycles divided by the number of stimulation cycles

  3 months

Secondary Outcomes (4)

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

  3 months

• Endometrial thickness on day of triggering of oocyte maturation

  3 months

• Clinical pregnancy rate

  6-8 weeks gestational age

• Incidence of early ovarian hyperstimulation syndrome (OHSS)

  Within 9 days of final triggering of oocyte maturation

Study Arms (2)

Clomiphene citrate-HCG group

ACTIVE COMPARATOR

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

Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)

Clomiphene citrate group

ACTIVE COMPARATOR

Women will receive clomiphene citrate alone

Drug: Clomiphene citrate

Interventions

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)

Also known as: Clomid and Choriomon

Clomiphene citrate-HCG group

Clomiphene citrate DRUG

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

Also known as: Clomid

Clomiphene citrate group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Sayed Abdelhafez: lead

Study Sites (1)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, 35111, Egypt

Location

Related Publications (1)

• Thabet 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 DERIVED

MeSH Terms

Conditions

Infertility; Polycystic Ovary Syndrome

Interventions

Clomiphene; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Mahmoud Thabet, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Khaled S Ismael, MD

  Mansoura University

  STUDY DIRECTOR

• Ahmed Ragab, MD

  Mansoura University

  STUDY DIRECTOR

• Maged R Elshamy, MD

  Mansoura University

  STUDY DIRECTOR

• Mohamed A Elnegery, MD

  Mansoura University

  STUDY DIRECTOR

• Hamed Youssef, MD

  Mansoura University

  STUDY DIRECTOR

• Mahmoud M Abdel-razik, MD

  Mansoura University

  STUDY DIRECTOR

• Mohamed S Abdelhafez, MD

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 2, 2015
• First Posted: May 6, 2015
• Study Start: March 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)