Letrozole vs. Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes.

NCT07616973 | Active Not Recruiting Phase 3

• 1 other identifier: SANA2023-LECLO03
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Infertility is a common reproductive health problem. Ovulation induction is a key treatment for women with anovulatory infertility. Letrozole and clomiphene citrate are widely used medications for ovulation induction. Tamoxifen has also been used as an alternative or adjunct therapy. This randomized clinical trial aims to compare the effectiveness of letrozole versus clomiphene citrate combined with tamoxifen for ovulation induction and pregnancy outcomes in infertile women. The outcomes include ovulation rate, pregnancy rate, endometrial thickness, follicular development, Miscarriage rate, and Live birth rate. The study will be conducted at Al-Thawra Hospital in Sana'a, Yemen, under the supervision of Sana'a University. Keywords: Infertility, Ovulation Induction, Letrozole, Clomiphene Citrate, Tamoxifen

Conditions

Infertility Drugs; Infertility Involuntary

Keywords

Ovulation induction; Clomiphene citrate; Tamoxifen; Letrozole; Anovulation; Infertility; PCOS; Polycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

• Ovulation rate

  The primary outcome is the rate of ovulation among participants, assessed by ultrasound monitoring of follicular development and serum hormone levels.

  During three treatment cycles, from days 10 to 16 of each cycle, adjustments will be made based on individual variations in menstrual cycle length (cycle length: 21-35 days).

Secondary Outcomes (3)

• clinical pregnancy rate .

  Pregnancy was confirmed in three treatment cycles (cycle length 21-35 days) through serum beta-hCG testing two weeks post-ovulation, followed by a transvaginal ultrasound showing a gestational sac four to six weeks later.

• Endometrial thickness

  During each of the three treatment cycles, from cycle day 10 until the administration of the ovulation trigger, adjustments were made based on individual variations in menstrual cycle length(21-35 days).

• Adverse Events/ Side effect

  From day 2 of the menstrual cycle (initiation of ovulation induction treatment) through up to 3 treatment cycles (cycle length: 21-35 days), until 2 weeks after the ovulation trigger.

Study Arms (2)

Letrazole Group

EXPERIMENTAL

Participants receive letrazole for ovulation induction according to the study protocol and are followed to evaluate ovulation and pregnancy outcomes.

Drug: Letrozole

Clomiphene Citrate + Tamoxifen

EXPERIMENTAL

Participants receive Clomiphene citrate and tamoxifen for ovulatory induction according to the study protocol and are followed to assess ovulatory and pregnancy outcomes.

Drug: Clomiphene Citrate + Tamoxifen

Interventions

Letrozole DRUG

Letrozole was administered for ovulation induction in infertile women according to the study protocol.

Letrazole Group

Clomiphene Citrate + Tamoxifen DRUG

Clomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol.

Clomiphene Citrate + Tamoxifen

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women are eligible for participation because the study evaluated ovulation induction treatments and pregnancy outcomes in infertile female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 18 and 40 years.
• Patients with anovulatory polycystic ovaries.
• Presence of a normal uterus and patent fallopian tubes, as confirmed by hysterosalpingography (HSG).
• Husband's semen analysis within normal parameters.
• Normal serum prolactin and thyroid-stimulating hormone (TSH) levels.

You may not qualify if:

• Spontaneous pregnancy.
• Women with hyperprolactinemia or thyroid dysfunction.
• Active liver disease or renal disease.
• Documented pelvic diseases such as endometriosis, ovarian pathology, hydro- or pyosalpinx, or uterine fibroids.
• Previous history of ovarian drilling.
• Contraindications to letrozole, clomiphene citrate, or tamoxifen.
• History of hypersensitivity reactions to study medications.

Sponsors & Collaborators

• Sana'a University: lead
• Al-Thawra Modern General Hospital: collaborator

Study Sites (1)

Al-Thawra Hospital

Sanaa, Sana'a, Yemen

Location

MeSH Terms

Conditions

Anovulation; Infertility; Polycystic Ovary Syndrome

Interventions

Letrozole; Clomiphene; Tamoxifen

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; Ovarian Cysts; Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ghada Abdullatef Al-Rajami, MD

  Sana'a University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Candidate in obstetrics and gynecology

Model Details: Participants will be randomly assigned to one of two parallel groups. Group 1 will receive Letrozole, while Group 2 will receive Clomiphene Citrate combined with Tamoxifen. Treatment and monitoring will continue according to the study protocol, including ultrasound assessment of follicular development, measurement of endometrial thickness, and monitoring of ovulation and pregnancy outcomes.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start: May 1, 2023
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)