Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate

NCT07462065 | Recruiting Phase 4 DMC

• 1 other identifier: PGHI-IRB (DMe)-RCD-06-098
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. All participants will also take clomiphene citrate 150 mg daily from day 3 to day 7 of the menstrual cycle. A transvaginal ultrasound will be performed on day 10 of the menstrual cycle to assess the growth of ovarian follicles, and the number of mature follicles (16-24 mm) will be recorded. If at least one mature follicle measuring 16-24 mm is present and the endometrial thickness is at least 7 mm, an injection of human chorionic gonadotropin (hCG) will be given to trigger ovulation, followed by an intrauterine insemination (IUI) procedure. Participants will be followed until the end of the menstrual cycle, and if the menstrual period is delayed by 5 days, a blood test for β-hCG will be performed to confirm pregnancy. Any side effects during the treatment period, such as swelling, fluid retention, blurred vision, or weight gain, will be recorded.

Conditions

Infertility Treatment; Pregnancy Rates

Keywords

Clomiphene citrate; Pioglitazone

Outcome Measures

Primary Outcomes (1)

• Ovarian stimulation rate

  This will be determined by no. of large size follicles (16-24mm in size) recruited following treatment on 10th day of menstrual cycle using transvaginal ultrasound to measure the size and no. of follicles.

  10th day of menstrual cycle

Secondary Outcomes (1)

• Pregnancy rates

  5th day after end of menstrual cycle

Study Arms (2)

Group C

ACTIVE COMPARATOR

Drug: Clomiphene Citrate.

Group CP

ACTIVE COMPARATOR

Drug: Pioglitazone (PIO) + Clomiphene citrate

Interventions

Clomiphene Citrate. DRUG

150 mg clomiphene citrate will be administered at third and seventh days of the menstrual cycle

Group C

Pioglitazone (PIO) + Clomiphene citrate DRUG

Patients will receive 30 mg pioglitazone daily; from the second day of menstruation along with 150 mg clomiphene citrate will be administered to both groups between the third and seventh days of the menstrual cycle.

Group CP

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal hysterosalpingography Normal spermogram Suffering from PCOS Ovarian cysts less than 20mm.

You may not qualify if:

• History of chronic cardiovascular disease Chronic kidney disease Diabetes Thyroid disease Pulmonary disease

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

Pakistan Atomic Energy Commission Hospital

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• Amirian M, Shariat Moghani S, Jafarian F, Mirteimouri M, Nikdoust S, Niroumand S, Salehi M, Payrovnaziri A. Combination of pioglitazone and clomiphene citrate versus clomiphene citrate alone for infertile women with the polycystic ovarian syndrome. BMC Womens Health. 2021 Aug 17;21(1):302. doi: 10.1186/s12905-021-01448-5.

  PMID: 34404415 BACKGROUND

MeSH Terms

Interventions

Clomiphene; Pioglitazone; Pemoline

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazoles

Study Officials

• Musarat Ashraf, MBBS,FCPS

  Head of Department

  STUDY CHAIR

Central Study Contacts

Kinza Principal Investigator, MBBS

CONTACT

+92-333-3275552; kinza.azharr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigataor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)