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Evaluation of effectivness of clomiphene plus Letrozole versus Clomiphene plus HMG in female infertility.

Comparison of induction and ovulation with Clomiphene plus Letrozole versus Clomiphene plus HMG in Clomiphene resistant polycystic ovary syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015090323621N3
Enrollment
200
Registered
2015-12-11
Start date
2015-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female infertility. Female infertility associated with anovulation

Interventions

Intervention 1: Intervention group 1: 100 mg of Clomiphene (Ovumid
Iran Hormone, Tehran, Iran) daily starting day 5 of the menses for 7 days plus 5 mg of Letrozole (Letrozole 2.5
SOHA Pharmaceutical Co, Tehran, Iran) daily starting day 5 of the menses for 5 days. Intervention 2: Intervention group 2: 100 mg of Clomiphene (Ovumid
Iran Hormone, Tehran, Iran) daily starting day 3 of the menses for 5 days plus HMG 150 I.U(Merional
IBSA Institute Biochimique SA, CH-6903 Lugano).
Treatment - Drugs
Intervention group 1: 100 mg of Clomiphene (Ovumid
SOHA Pharmaceutical Co, Tehran, Iran) daily starting day 5 of the menses for 5 days.
Intervention group 2: 100 mg of Clomiphene (Ovumid
IBSA Institute Biochimique SA, CH-6903 Lugano)

Sponsors

Vice Chancellor for research of Iran Univercity of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Women with history of infertility more over than one year and diagnosis of PCOS based on the revised 2003 consensus on diagnostic criteria; By clomiphene resistance that meant failure of ovulation after 100-150 mg CC for 5 days for 2-3 cycles and then resistant to letrozole 2.5 mg daily for 5 days for 2 cycles. Exclusion criteria: Women older than 40 years or younger than 20; fallopian tubes abnormality proved by hysterosalpingography; abnormal semen analysis for their partners according to the modified criteria of the World Health Organization; endocrine problem like hyper or hypo thyroidism, hyperprolactinemia; abnormal karyotype.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Ovulation. Timepoint: Day 11 of the menstrual cycle. Method of measurement: Transvaginal ultrasound.;Pregnancy. Timepoint: After retard of mense. Method of measurement: Pregnancy test by missuring B-hCG.;The number of follicles. Timepoint: Day 11 of the menstrual cycle. Method of measurement: Transvaginal ultrasound.;Follicle size. Timepoint: Day 11 of the menstrual cycle. Method of measurement: Transvaginal ultrasound.;Endometrial thickness. Timepoint: Day 11 of the menstrual cycle. Method of measurement: Transvaginal ultrasound.

Secondary

MeasureTime frame
Multiple pregnancies. Timepoint: 4-6 weeks after menstural delay. Method of measurement: pregnancy sonography.;Abortions under 20 weeks. Timepoint: after pegnancy. Method of measurement: pregnancy sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sara Norouzi

Iran University of Medical Sciences

sr.norouzi@yahoo.com+98 21 5563 2277

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026