SubfertilityPhase 4NCT04331197
BMI Effect on the Response to Ovulation Induction in Letrozole vs Clomid
A Phase 4 study testing Clomiphene Citrate 50mg and Letrozole 2.5mg in people with Subfertility, run by Cairo University.
Trial summary
There is an increased prevalence of high Body mass index (BMI) all over the world.High BMI is shown to have an impact on the female reproductive system.It can contribute to both ovulatory and anovulatory subfertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Clomiphene Citrate 50mg and Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-45 years old.
- History of subfertility for 2 years.
- No previous IVF
- Intact tubes as evidenced by HSG or Hycosy
- Normal Sperm parameters according to WHO criteria.
- Ability to have regular intercourse during the ovulation induction phase of the study.
Who cannot join
- Age less than 18 years old or older than 45 years old.
- FSH> 15 mIU/ml
- Tubal factor of infertility
- Male factor of infertility
- Current pregnancy,abnormal uterine bleeding.
- History of use of hormonal contraception in the last 3 months.
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- Untreated medical problems: thyroid disease,hyperprolactinemia or contraindication to pregnancy as uncontrolled diabetes or severe heart disease.
- Contraindications to clomiphene citrate: hypersensitivity to clomid.
- Contraindications to letrozole: hypersensitivity to letrozole .
Trial locations and contacts
No sites are listed yet.
Amira Saeed, MD contact
About this study
Official title: Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid
There is an increased prevalence of high Body mass index (BMI) all over the world.High BMI is shown to have an impact on the female reproductive system.It can contribute to both ovulatory and anovulatory subfertility.
Clomiphene citrate and Letrozole have been used for treatment of infertility.Both are used for induction of ovulation.
Read more
Clomiphene citrate is an estrogen receptor antagonist .It increases serum FSH and it has its limitation due to his antiestrogenic effect,it has an ovulation rate 70-80% but pregnancy rate is only 22% because of its anti-estrogenic effect on endometrium and poor cervical mucus (Legro RS et al.,2007) Letrozole is an aromatase inhibitor which inhibits the production of estrogen, which influences the action of the brain's hypothalamus and pituitary on the functioning of the ovaries by increasing FSH.Due to the antiestrogenic effect of clomiphene citrate,Letrozole can be used as an alternative.
The investigators are comparing the effect of both medications on the outcome of the induction of ovulation in women with high BMI.
Read the detailed description
This is a Randomized controlled trial .The researchers include160 women with BMI more than 30 who were suffering from subfertility for more than 2 years. The investigators will randomise them into 2 groups. Group A:They were prescribed 100 mg of clomiphene citrate from day 2-5 of the cycle for 5 days. Group B : They were prescribed 5 mg of Letrozole from day 2-5 of the cycle.
Vaginal ultrasound was performed on day 11 of the cycle, After at least one follicle reached 15 mm, The patient was encouraged to have sexual intercourse every other day for few days.The patients will have a midluteal progesterone level to confirm ovulation and will have a pregnancy test in 2 weeks if missed period. The researchers will compare the number of mature follicles, endometrial thickness on the day when there are mature follicles, occurrence of pregnancy, multiple pregnancies, and miscarriages .
- Conditions
- Subfertility
- Being tested
- Clomiphene Citrate 50mg, Letrozole 2.5mg
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate 50mgDrug
Also called Clomid
Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
Letrozole 2.5mgDrug
Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene Citrate-High BMI women | Active comparator | Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days Receives: Drug: Clomiphene Citrate 50mg |
| Letrozole-High BMI women | Active comparator | Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days Receives: Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of ovulation
Raised concentration of serum progesterone
Measured: day 21 of 28 day cycle or 7 days post LH surge
Secondary outcomes (4)
Number of mature follicles
Number of follicles> 15mm
Measured: day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Endometrial thickness
the thickest part of the endometrial lining at the longitudinal plane at the time of mature follicle
Measured: day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Conception
Number of participants with positive pregnancy test (serum or urine),serum BHCG > 25 IU/L
Measured: 4-5 weeks post treatment
clinical pregnancy
Number of participants with gestational sac with positive fatal pulsation
Measured: 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elkattan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331197
- Sponsor's protocol ID
- Protocol 600
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid
- ClinicalTrials.gov ID
- NCT04331197
- Acronym / sponsor ID
- Protocol 600
- Conditions
- Subfertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 2 Apr 2020 (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.
There is an increased prevalence of high Body mass index (BMI) all over the world.High BMI is shown to have an impact on the female reproductive system.It can contribute to both ovulatory and anovulatory subfertility.
Clomiphene citrate and Letrozole have been used for treatment of infertility.Both are used for induction of ovulation.
Clomiphene citrate is an estrogen receptor antagonist .It increases serum FSH and it has its limitation due to his antiestrogenic effect,it has an ovulation rate 70-80% but pregnancy rate is only 22% because of its anti-estrogenic effect on endometrium and poor cervical mucus (Legro RS et al.,2007) Letrozole is an aromatase inhibitor which inhibits the production of estrogen, which influences the action of the brain's hypothalamus and pituitary on the functioning of the ovaries by increasing FSH.Due to the antiestrogenic effect of clomiphene citrate,Letrozole can be used as an alternative.
The investigators are comparing the effect of both medications on the outcome of the induction of ovulation in women with high BMI.
Detailed description
This is a Randomized controlled trial .The researchers include160 women with BMI more than 30 who were suffering from subfertility for more than 2 years. The investigators will randomise them into 2 groups. Group A:They were prescribed 100 mg of clomiphene citrate from day 2-5 of the cycle for 5 days. Group B : They were prescribed 5 mg of Letrozole from day 2-5 of the cycle.
Vaginal ultrasound was performed on day 11 of the cycle, After at least one follicle reached 15 mm, The patient was encouraged to have sexual intercourse every other day for few days.The patients will have a midluteal progesterone level to confirm ovulation and will have a pregnancy test in 2 weeks if missed period. The researchers will compare the number of mature follicles, endometrial thickness on the day when there are mature follicles, occurrence of pregnancy, multiple pregnancies, and miscarriages .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene Citrate-High BMI women | Active comparator | Drug: Clomiphene Citrate 50mgClomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days |
| Letrozole-High BMI women | Active comparator | Drug: Letrozole 2.5mgFemara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-45 years old.
- History of subfertility for 2 years.
- No previous IVF
- Intact tubes as evidenced by HSG or Hycosy
- Normal Sperm parameters according to WHO criteria.
Key exclusion criteria (9 listed)
- Age less than 18 years old or older than 45 years old.
- FSH> 15 mIU/ml
- Tubal factor of infertility
- Male factor of infertility
- Current pregnancy,abnormal uterine bleeding.
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 |
|---|---|---|
| Clomiphene Citrate 50mgAlso: ClomidClomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days | Drug | Clomiphene Citrate-High BMI women |
| Letrozole 2.5mgFemara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days | Drug | Letrozole-High BMI women |
Primary outcome
Evidence of ovulation
Time frame: day 21 of 28 day cycle or 7 days post LH surge
Raised concentration of serum progesterone
4 secondary outcomes
Number of mature follicles
Time frame: day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Endometrial thickness
Time frame: day 12-19 of the cycle (At the end of the treatment cycles, each cycle 28 days)
Conception
Time frame: 4-5 weeks post treatment
clinical pregnancy
Time frame: 6 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Amira Saeed, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clomiphene Citrate 50mg and Letrozole 2.5mg in people with Subfertility, run by Cairo University.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Elkattan, MD,MRCOG,DFSRH (01212529213, emyelkattan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of ovulation (time frame: day 21 of 28 day cycle or 7 days post LH surge). 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 2 Apr 2020.