Letrozole vs. Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes. (LET-CC-TAM)

May 28, 2026 updated by: Ghada Abdullatef Mahmood Al-Rajami, Sana'a University

Letrozole Versus Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes in Infertile Women: A Randomized Clinical Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Infertility affects a significant proportion of women worldwide and is often associated with ovulatory dysfunction. While letrozole and clomiphene citrate are standard treatments for ovulation induction, their comparative effectiveness alongside tamoxifen as adjunct therapy remains under investigation.

Infertility affects a significant proportion of women worldwide and is often associated with ovulatory dysfunction. While letrozole and clomiphene citrate are standard treatments for ovulation induction, their comparative effectiveness alongside tamoxifen as adjunct therapy remains under investigation.

This study is a randomized clinical trial enrolling women with anovulatory infertility. Participants will be assigned to receive either letrozole alone or clomiphene citrate combined with tamoxifen. Ovulation will be monitored using ultrasound and hormonal assays. Pregnancy outcomes will be recorded and analyzed to compare efficacy between the two treatment groups.

Endometrial thickness and follicular development will be evaluated throughout the treatment cycles. All participants provide informed consent before enrollment, and the study is conducted under the approval of the Sana'a University Ethics Committee at Al-Thawra Hospital, Sana'a, Yemen.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Yemen
    • Sana'a
      • Sanaa, Sana'a, Yemen
        • Al-Thawra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrazole Group
Participants receive letrazole for ovulation induction according to the study protocol and are followed to evaluate ovulation and pregnancy outcomes.
Drug: Letrozole
Letrozole was administered for ovulation induction in infertile women according to the study protocol.
Experimental: Clomiphene Citrate + Tamoxifen
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
Clomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation rate
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate .
Time Frame: 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.
presence of a clinical pregnancy confirmed by transvaginal ultrasound visualization of a gestational sac with fetal heartbeat after ovulation induction treatment.
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
Time Frame: 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).
Measurement of Endometrial thickness in millimeters using transvaginal ultrasound on the day of ovulation trigger during ovulation induction treatment cycles.
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
Time Frame: 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.
Incidence of adverse events (CTCAE v5.0 grades 1-3 ), including nausea, headache, hot flushes, and ovarian hyperstimulation syndrome ( OHSS), was assessed by patient questionnaire per ovulation induction cycles.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana'a University

Collaborators

Al-Thawra Modern General Hospital

Investigators

  • Principal Investigator: Ghada Abdullatef Al-Rajami, MD, Sana'a University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SANA2023-LECLO03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study involves sensitive clinical information of infertile women, and sharing these data compromises participant privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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