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

Sana'a University

Status and phase: Active, not recruiting; Phase 3

Conditions: Infertility Drugs; Infertility Involuntary

Treatments: Drug: Clomiphene Citrate + Tamoxifen; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT07616973

SANA2023-LECLO03

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Letrazole Group

Experimental group

Description:

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

Treatment:

Drug: Letrozole

Clomiphene Citrate + Tamoxifen

Experimental group

Description:

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

Treatment:

Drug: Clomiphene Citrate + Tamoxifen