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| Name | Class |
|---|---|
| Al-Thawra Modern General Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrazole Group | Experimental | Participants receive letrazole for ovulation induction according to the study protocol and are followed to evaluate ovulation and pregnancy outcomes. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole was administered for ovulation induction in infertile women according to the study protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate . | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women are eligible for participation because the study evaluated ovulation induction treatments and pregnancy outcomes in infertile female patients.
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| Name | Affiliation | Role |
|---|---|---|
| Ghada Abdullatef Al-Rajami, MD | Sana'a University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Thawra Hospital | Sanaa | Sana'a | Yemen |
The study involves sensitive clinical information of infertile women, and sharing these data compromises participant privacy and confidentiality.
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| ID | Term |
|---|---|
| D000858 | Anovulation |
| D007246 | Infertility |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D002996 | Clomiphene |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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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.
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| Clomiphene Citrate + Tamoxifen | Drug | Clomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol. |
|
| Endometrial thickness | 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 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |