Infertility Drugs, Infertility Involuntary
Conditions
Keywords
Ovulation induction, Clomiphene citrate, Tamoxifen, Letrozole, Anovulation, Infertility, PCOS, Polycystic ovary syndrome
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
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.
Interventions
DRUGLetrozole
Letrozole was administered for ovulation induction in infertile women according to the study protocol.
DRUGClomiphene Citrate + Tamoxifen
Clomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol.
Sponsors
Sana'a University
Al-Thawra Modern General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | presence of a clinical pregnancy confirmed by transvaginal ultrasound visualization of a gestational sac with fetal heartbeat after ovulation induction treatment. |
| 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). | Measurement of Endometrial thickness in millimeters using transvaginal ultrasound on the day of ovulation trigger during ovulation induction treatment cycles. |
| 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. | 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. |
Countries
Yemen
Contacts
PRINCIPAL_INVESTIGATORGhada Abdullatef Al-Rajami, MD
Sana'a University
Outcome results
None listed