InfertilityPhase 1NCT02493933
Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients
A Phase 1 study testing Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine in people with Infertility, run by Kasr El Aini Hospital.
Trial summary
To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly divided to 3 groups for induction of ovulation. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2015
- Phase
- Phase 1
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients have PCOS.
- All patients received CC 100 mg/day for 5 days starting from day 5 with successful ovulation as documented by folliculometry and midluteal serum progesterone with no pregnancy achieved.
- All patients have patent fallopian tubes by Hysterosalpingography.
- Their husbands have normal semen analysis according to the modified criteria of WHO.
- All patients have normal serum prolactin and thyroid profile.
- Any patient having vaginitis was treated before starting induction.
Who cannot join
- Other causes of infertility than anovulation.
- Diabetes or other endocrinological disorders.
- Age > 40 years.
- Smoking.
- Alcohol use.
- Presence of ovarian cyst >2cm on the second day of the cycle.
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- Patients who have received gonadotrophins in the preceeding 6 months.
- Patients who have done unilateral or bilateral ovarian drilling.
- Allergy to PE, NO donors or NAC
About this study
Official title: Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene
To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80] received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80] patients received CC 100 mg/d plus NAC 1200 mg/day.
- Conditions
- Infertility
- Being tested
- Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteineDrug
| Study group | Role | What they receive |
|---|---|---|
| Phytoestrogen | Active comparator | Patients received oral PE 120 mg/ day in the form of dry coated tablets (Klimadynon, Bionorica, Germany) 2 tablets three times daily from day 1 to day 12 as adjuvant to CC in the follicular phase of the cycle. Receives: Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine |
| Isosorbid mononitrate | Active comparator | Patients received in addition to CC 20 mg Isosorbid mononitrate (ISMN) tablet (EFFOX, Minapharm Co., Egypt under licence of Shwartz pharma,Germany) applied vaginally from day 1 to day 12 of the cycle. Receives: Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine |
| N-Acetyl cysteine | Active comparator | Patients received supplementation to CC with NAC 1200 mg/day orally (N-acetyl cysteine, Sedico, Cairo, ARE) sachets 200 mg each, as two sachets thrice daily from day 1 to day 12 of the cycle. Receives: Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawara Mohamed Hashish, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493933
- Sponsor's protocol ID
- 43-2015
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene
- ClinicalTrials.gov ID
- NCT02493933
- Acronym / sponsor ID
- 43-2015
- Conditions
- Infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- 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.
To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80] received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80] patients received CC 100 mg/d plus NAC 1200 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phytoestrogen | Active comparator | Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteinePatients received oral PE 120 mg/ day in the form of dry coated tablets (Klimadynon, Bionorica, Germany) 2 tablets three times daily from day 1 to day 12 as adjuvant to CC in the follicular phase of the cycle. |
| Isosorbid mononitrate | Active comparator | Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteinePatients received in addition to CC 20 mg Isosorbid mononitrate (ISMN) tablet (EFFOX, Minapharm Co., Egypt under licence of Shwartz pharma,Germany) applied vaginally from day 1 to day 12 of the cycle. |
| N-Acetyl cysteine | Active comparator | Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteinePatients received supplementation to CC with NAC 1200 mg/day orally (N-acetyl cysteine, Sedico, Cairo, ARE) sachets 200 mg each, as two sachets thrice daily from day 1 to day 12 of the cycle. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All patients have PCOS.
- All patients received CC 100 mg/day for 5 days starting from day 5 with successful ovulation as documented by folliculometry and midluteal serum progesterone with no pregnancy achieved.
- All patients have patent fallopian tubes by Hysterosalpingography.
- Their husbands have normal semen analysis according to the modified criteria of WHO.
- All patients have normal serum prolactin and thyroid profile.
Key exclusion criteria (9 listed)
- Other causes of infertility than anovulation.
- Diabetes or other endocrinological disorders.
- Age > 40 years.
- Smoking.
- Alcohol use.
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 |
|---|---|---|
| Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine | Drug | Isosorbid mononitrate, N-Acetyl cysteine, Phytoestrogen |
Primary outcome
clinical pregnancy rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine in people with Infertility, run by Kasr El Aini Hospital.
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 14 Jul 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
clinical pregnancy rate (time frame: 6 months). 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 14 Jul 2015.