Unexplained InfertilityPhase 4NCT06178523
Cost-effective Treatment of Unexplained Infertility
A Phase 4 study testing Clomiphene Citrate., Sildenafil Citrate and Intrauterine Insemination in people with Unexplained Infertility, run by Batterjee Medical College at 1 site in Saudi Arabia.
Trial summary
The issue of unexplained infertility that Southam brought up in 1960 is still a problem today. Despite improvements in infertility assessment, many couples still don't know why they are infertile. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Clomiphene Citrate., Sildenafil Citrate and Intrauterine Insemination
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Saudi women.
- Married women in a stable, continuous, unprotected heterosexual relationship (cohabitating with their husbands).
- Aged between 18 to 35 years old.
- Non-smoking.
- Non-alcohol drinking.
- With a body mass index < 30 Kg/M2,
- Who are looking healthy (all their infertility-workup investigations including male partners' seminal analysis were within normal range)
- Failed to conceive spontaneously within 2 years of marriage without evident cause (cases with primary infertility).
Who cannot join
- All non-Saudi women,
- Saudi unmarried women (not yet engaged in sexual activity),
- Married women with age less than 18 or more than 35 years old,
- Patients with secondary infertility,
- Cigarette smokers.
- Alcohol drinking.
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- BMI > 30 Kg/M2,
- Pregnant women.
- Breastfeeding women.
- With known pathological cause (either male or female factor),
- With hypersensitivity to any of medication planned to be used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study
The issue of unexplained infertility that Southam brought up in 1960 is still a problem today. Despite improvements in infertility assessment, many couples still don't know why they are infertile. Even with the use of the most advanced ovulation detectors, fallopian tube patency tests, and semen evaluations, competency cannot identify every potential flaw in the intricate processes leading to conception. Unexplained infertility will be a challenge for both biological and clinical researchers since it results from these gaps in our understanding of fertilization and from our incapacity to use all of the current evidence-based information.
Read the detailed description
For the treatment of unexplained infertility, Clomiphene Citrate (CC) is frequently used either alone or in conjunction with intrauterine insemination (IUI). Its combined oestrogenic and anti-oestrogenic characteristics serve as the basis for the mechanism of action. When clomiphene citrate is used, the uterine blood flow is reduced during the peri-implantation stage of early luteal phase. About 80% of women experience ovulation, which has a cumulative effect over 6 to 8 months, yet the pregnancy rate in these women can still be relatively low. The endometrial and cervical mucus-level anti-oestrogenic actions of CC are the potential culprits. Without a doubt, one of the biggest obstacles in treating infertility is the endometrial impact. If the endometrial thickness (ET) is less than 6 mm, the pregnancy rate may be extremely low.
Sildenafil citrate promotes endometrial thickness and uterine blood flow. The capacity of the blastocyst to penetrate the endometrium and establish a lasting blood supply is crucial for successful implantation. To do this, the blastocyst needs genes in order to create the required proteins for breaking down the endometrial cellular matrix, control cell development, and trigger angiogenesis.
It can be difficult to understand the evidence on the efficacy and security of therapy for unexplained infertility. Given the substantial proportion of unaided pregnancies with expectant management, it is problematic that most studies do not include a placebo or untreated control group.
- Conditions
- Unexplained Infertility
- Being tested
- Clomiphene Citrate., Sildenafil Citrate, Intrauterine Insemination
- Keywords
- Clomiphene citrate, Sildenafil citrate, Intrauterine insemination, Unexplained Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate.Drug
Also called Clomid®
Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle (Groups A, B, and C).
Sildenafil CitrateDrug
Also called Viagra®
Sildenafil Acetate (Viagra®) 25 mg as a vaginal tablet 6 hourly for 10 days starting from the fifth day of the menstrual cycle (Group-A).
Intrauterine InseminationProcedure or surgery
Also called IUI
IUI (Group-B).
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil & Clomiphene Group | Active comparator | Sildenafil Acetate (Viagra®) 25 mg as a vaginal tablet 6 hourly for 10 days starting from the fifth day of the menstrual cycle + Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle.
Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound. Receives: Drug: Clomiphene Citrate.; Drug: Sildenafil Citrate |
| IUI & Clomiphene Group | Active comparator | Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle + Intrauterine insemination (IUI) 42 hours after human chorionic gonadotropin (Pregnyl®) 10,000 IU injection IM.
Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound. Receives: Drug: Clomiphene Citrate.; Procedure: Intrauterine Insemination |
| Clomiphene only Group | Placebo comparator | Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle.
Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound. Receives: Drug: Clomiphene Citrate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome
Ultrasound confirmation of intrauterine fetal heartbeat.
Measured: 7 weeks after positive pregnancy test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couples with unexplained infertility (n=900) were divided into three equal groups. Group-A received Sildenafil Citrate (Viagra®) and Clomiphene Citrate (Clomid®). Group-B received Clomiphene Citrate (Clomid®) and subjected to intra-uterine insemination (IUI). Group-C received Clomiphen Citrate (Clomid®) alone (Control group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remah Moustafa Kamel, Batterjee Medical College
- Investigators
- Remah M Kamel, PhD, Principal investigator, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178523
- Sponsor's protocol ID
- RES/2024/1
- Status last verified
- Feb 2025
- First submitted
- 27 Aug 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06178523
- Acronym / sponsor ID
- RES/2024/1
- Conditions
- Unexplained Infertility
- Keywords
- Clomiphene citrate, Sildenafil citrate, Intrauterine insemination, Unexplained Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Dec 2023 (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.
The issue of unexplained infertility that Southam brought up in 1960 is still a problem today. Despite improvements in infertility assessment, many couples still don't know why they are infertile. Even with the use of the most advanced ovulation detectors, fallopian tube patency tests, and semen evaluations, competency cannot identify every potential flaw in the intricate processes leading to conception. Unexplained infertility will be a challenge for both biological and clinical researchers since it results from these gaps in our understanding of fertilization and from our incapacity to use all of the current evidence-based information.
Detailed description
For the treatment of unexplained infertility, Clomiphene Citrate (CC) is frequently used either alone or in conjunction with intrauterine insemination (IUI). Its combined oestrogenic and anti-oestrogenic characteristics serve as the basis for the mechanism of action. When clomiphene citrate is used, the uterine blood flow is reduced during the peri-implantation stage of early luteal phase. About 80% of women experience ovulation, which has a cumulative effect over 6 to 8 months, yet the pregnancy rate in these women can still be relatively low. The endometrial and cervical mucus-level anti-oestrogenic actions of CC are the potential culprits. Without a doubt, one of the biggest obstacles in treating infertility is the endometrial impact. If the endometrial thickness (ET) is less than 6 mm, the pregnancy rate may be extremely low.
Sildenafil citrate promotes endometrial thickness and uterine blood flow. The capacity of the blastocyst to penetrate the endometrium and establish a lasting blood supply is crucial for successful implantation. To do this, the blastocyst needs genes in order to create the required proteins for breaking down the endometrial cellular matrix, control cell development, and trigger angiogenesis.
It can be difficult to understand the evidence on the efficacy and security of therapy for unexplained infertility. Given the substantial proportion of unaided pregnancies with expectant management, it is problematic that most studies do not include a placebo or untreated control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Couples with unexplained infertility (n=900) were divided into three equal groups. Group-A received Sildenafil Citrate (Viagra®) and Clomiphene Citrate (Clomid®). Group-B received Clomiphene Citrate (Clomid®) and subjected to intra-uterine insemination (IUI). Group-C received Clomiphen Citrate (Clomid®) alone (Control group).
| Arm | Type | Receives |
|---|---|---|
| Sildenafil & Clomiphene Group | Active comparator | Drug: Clomiphene Citrate., Drug: Sildenafil CitrateSildenafil Acetate (Viagra®) 25 mg as a vaginal tablet 6 hourly for 10 days starting from the fifth day of the menstrual cycle + Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle. Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound. |
| IUI & Clomiphene Group | Active comparator | Drug: Clomiphene Citrate., Procedure: Intrauterine InseminationClomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle + Intrauterine insemination (IUI) 42 hours after human chorionic gonadotropin (Pregnyl®) 10,000 IU injection IM. Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound. |
| Clomiphene only Group | Placebo comparator | Drug: Clomiphene Citrate.Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle. Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Saudi women.
- Married women in a stable, continuous, unprotected heterosexual relationship (cohabitating with their husbands).
- Aged between 18 to 35 years old.
- Non-smoking.
- Non-alcohol drinking.
Key exclusion criteria (11 listed)
- All non-Saudi women,
- Saudi unmarried women (not yet engaged in sexual activity),
- Married women with age less than 18 or more than 35 years old,
- Patients with secondary infertility,
- Cigarette smokers.
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.Also: Clomid®Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle (Groups A, B, and C). | Drug | Clomiphene only Group, IUI & Clomiphene Group, Sildenafil & Clomiphene Group |
| Sildenafil CitrateAlso: Viagra®Sildenafil Acetate (Viagra®) 25 mg as a vaginal tablet 6 hourly for 10 days starting from the fifth day of the menstrual cycle (Group-A). | Drug | Sildenafil & Clomiphene Group |
| Intrauterine InseminationAlso: IUIIUI (Group-B). | Procedure or surgery | IUI & Clomiphene Group |
Primary outcome
Pregnancy outcome
Time frame: 7 weeks after positive pregnancy test.
Ultrasound confirmation of intrauterine fetal heartbeat.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Remah M Kamel, PhD principal investigator
Batterjee Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clomiphene Citrate., Sildenafil Citrate and Intrauterine Insemination in people with Unexplained Infertility, run by Batterjee Medical College at 1 site in Saudi Arabia.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 13 Feb 2025. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pregnancy outcome (time frame: 7 weeks after positive pregnancy test.). 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 13 Feb 2025.