Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome

NCT02269306 | Completed DMC

• 1 other identifier: Menoufia OGG-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).

Conditions

Anovulation

Keywords

PCOS; clomiphene citrate; AMH; visceral fat area; HOMA-IR

Outcome Measures

Primary Outcomes (1)

• ovulation

  3 months ( cycles)

Study Arms (1)

clomiphen citrate(cc)

EXPERIMENTAL

Initial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles.

Drug: clomiphen citrate

Interventions

clomiphen citrate DRUG

The study was carried out on 150 patients with PCOS. Initial clomiphen citrate (CC) doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.

Also known as: clomid

clomiphen citrate(cc)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The study included 150 infertile women(age from 18 to 40 years) with PCOS diagnosed by the presence of at least two of the following \[15\]:
• Clinical hyperandrogenism: Hirsutism or acne vulgaris and/or biochemical hyperandrogenism (total testosterone \>88 ng/dl or DHEAS \>275 ug/dL)\[16\]. (2) Menstrual and/or ovulatory disturbances, mainly oligomenorrhea (interval between vaginal bleeding \>35 days and \< 6 months) or amenorrhea (bleeding interval \>6 months). (3) Polycystic ovaries as visualized by transvaginal ultrasound (either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume \>10 cm3).

You may not qualify if:

• Patients having one or more of these criteria were excluded; Age \<18 years or \>40 years, body mass index (BMI) \<18.5 kg/m2 or \>35 kg/m2, pregnancy, endocrine disorders, systemic disease, current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction or dopaminergic agents, use of antidiabetes, antiobesity drugs or history of tubal or ovarian surgery.

Sponsors & Collaborators

• Menoufia Obstetrics and Gynecology Group: lead

Study Sites (1)

Menoufia University hospital

Shebin Elkom, Menoufia, 11111, Egypt

Location

Related Publications (1)

• Ellakwa HE, Sanad ZF, Hamza HA, Emara MA, Elsayed MA. Predictors of patient responses to ovulation induction with clomiphene citrate in patients with polycystic ovary syndrome experiencing infertility. Int J Gynaecol Obstet. 2016 Apr;133(1):59-63. doi: 10.1016/j.ijgo.2015.09.008. Epub 2015 Dec 17.

  PMID: 26848057 DERIVED

MeSH Terms

Conditions

Anovulation

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Hamed El Ellakwa, MD

  Menoufiya faculty of medicine,menoufiya university,ministry of higher education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Hamed Ellakwa

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 21, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

EG (1)