Infertility DrugsPhase 3LET-CC-TAMNCT07616973
Letrozole vs. Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes.
A Phase 3 study testing Letrozole and Clomiphene Citrate + Tamoxifen in people with Infertility Drugs and Infertility Involuntary, run by Sana'a University at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility Drugs, Infertility Involuntary
- What is being tested?
- Letrozole and Clomiphene Citrate + Tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteYemen
- Study dates
- 1 May 2023to 30 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Infertility Drugs, Infertility Involuntary
- Being tested
- Letrozole, Clomiphene Citrate + Tamoxifen
- Keywords
- Ovulation induction, Clomiphene citrate, Tamoxifen, Letrozole, Anovulation, Infertility, PCOS, Polycystic ovary syndrome
- Medical subject headings
- Anovulation, Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole was administered for ovulation induction in infertile women according to the study protocol.
Clomiphene Citrate + TamoxifenDrug
Clomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Letrazole Group | Experimental | Participants receive letrazole for ovulation induction according to the study protocol and are followed to evaluate ovulation and pregnancy outcomes. Receives: 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. Receives: Drug: Clomiphene Citrate + Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
The primary outcome is the rate of ovulation among participants, assessed by ultrasound monitoring of follicular development and serum hormone levels.
Measured: 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 .
presence of a clinical pregnancy confirmed by transvaginal ultrasound visualization of a gestational sac with fetal heartbeat after ovulation induction treatment.
Measured: 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
Measurement of Endometrial thickness in millimeters using transvaginal ultrasound on the day of ovulation trigger during ovulation induction treatment cycles.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 May 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Thawra Modern General Hospital
- Responsible party
- Principal investigator, Ghada Abdullatef Mahmood Al-Rajami, Sana'a University
- Investigators
- Ghada Abdullatef Al-Rajami, MD, Principal investigator, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616973
- Sponsor's protocol ID
- SANA2023-LECLO03
- Acronym
- LET-CC-TAM
- Status last verified
- Mar 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study involves sensitive clinical information of infertile women, and sharing these data compromises participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Versus Clomiphene Citrate Plus Tamoxifen for Ovulation Induction and Pregnancy Outcomes in Infertile Women: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07616973
- Acronym / sponsor ID
- LET-CC-TAM / SANA2023-LECLO03
- Conditions
- Infertility Drugs, Infertility Involuntary
- Keywords
- Ovulation induction, Clomiphene citrate, Tamoxifen, Letrozole, Anovulation, Infertility, PCOS, Polycystic ovary syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Collaborators
- Al-Thawra Modern General Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Letrazole Group | Experimental | Drug: LetrozoleParticipants receive letrazole for ovulation induction according to the study protocol and are followed to evaluate ovulation and pregnancy outcomes. |
| Clomiphene Citrate + Tamoxifen | Experimental | Drug: Clomiphene Citrate + TamoxifenParticipants receive Clomiphene citrate and tamoxifen for ovulatory induction according to the study protocol and are followed to assess ovulatory and pregnancy outcomes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleLetrozole was administered for ovulation induction in infertile women according to the study protocol. | Drug | Letrazole Group |
| Clomiphene Citrate + TamoxifenClomiphene citrate combined with tamoxifen was administered for ovulation induction in infertile women according to the study protocol. | Drug | Clomiphene Citrate + Tamoxifen |
Primary outcome
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.
3 secondary outcomes
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. The study involves sensitive clinical information of infertile women, and sharing these data compromises participant privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada Abdullatef Al-Rajami, MD principal investigator
Sana'a University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole and Clomiphene Citrate + Tamoxifen in people with Infertility Drugs and Infertility Involuntary, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.