InfertilityPhase 4NCT02344888
Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS
A Phase 4 study testing Clomiphene citrate and Prednisolone and Clomiphene citrate and folic acid in people with Infertility and Polycystic Ovarian Syndrome, run by Mahmoud Thabet at 2 sites in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovarian Syndrome
- What is being tested?
- Clomiphene citrate and Prednisolone and Clomiphene citrate and folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesEgypt
- Study dates
- Feb 2015to Jan 2019
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile lean women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Who cannot join
- Age < 20 or > 35 years.
- Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- Metabolic or hormonal abnormalities
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Mahmoud M Abdelrazik, Dr, +201005548881, dr_mahmoudhosam@yahoo.com
- Recruiting
Private practice settings
Al Mansurah, Dakahlia Governorate
About this study
Official title: Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).
Read the detailed description
Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Being tested
- Clomiphene citrate and Prednisolone, Clomiphene citrate and folic acid
- Keywords
- PCOS, Clomiphene citrate resistant, Prednisolone
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrate and PrednisoloneDrug
Also called Clomid and Hostacortin-H
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)
Clomiphene citrate and folic acidDrug
Also called Clomid and folic acid
Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate-Prednisolone group | Active comparator | Women will receive clomiphene citrate and prednisolone Receives: Drug: Clomiphene citrate and Prednisolone |
| Clomiphene citrate-placebo group | Active comparator | Women will receive clomiphene citrate and folic acid 0.5mg (placebo) Receives: Drug: Clomiphene citrate and folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Number of ovulatory cycles divided by the number of stimulation cycles
Measured: 3 months
Secondary outcomes (3)
Number of ovarian follicles ≥ 18 mm on day of HCG administration
Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration
Measured: 3 months
Endometrial thickness on day of HCG administration
Endometrial thickness by TVS on day of HCG administration
Measured: 3 months
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
Measured: 6-8 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2019
- Study completionJan 2019 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Thabet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Thabet, Mansoura University
- Investigators
- Mahmoud M Abdelrazik, Dr, Principal investigator, Mansoura UniversityMahmoud Thabet, D, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344888
- Sponsor's protocol ID
- MMA1
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2015
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT02344888
- Acronym / sponsor ID
- MMA1
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Keywords
- PCOS, Clomiphene citrate resistant, Prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mahmoud ThabetUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Jan 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.
The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).
Detailed description
Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate-Prednisolone group | Active comparator | Drug: Clomiphene citrate and PrednisoloneWomen will receive clomiphene citrate and prednisolone |
| Clomiphene citrate-placebo group | Active comparator | Drug: Clomiphene citrate and folic acidWomen will receive clomiphene citrate and folic acid 0.5mg (placebo) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile lean women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Key exclusion criteria (7 listed)
- Age < 20 or > 35 years.
- Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
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 and PrednisoloneAlso: Clomid and Hostacortin-HWomen will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle) | Drug | Clomiphene citrate-Prednisolone group |
| Clomiphene citrate and folic acidAlso: Clomid and folic acidWomen will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle) | Drug | Clomiphene citrate-placebo group |
Primary outcome
Ovulation rate
Time frame: 3 months
Number of ovulatory cycles divided by the number of stimulation cycles
3 secondary outcomes
Number of ovarian follicles ≥ 18 mm on day of HCG administration
Time frame: 3 months
Endometrial thickness on day of HCG administration
Time frame: 3 months
Clinical pregnancy rate
Time frame: 6-8 weeks gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- 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.
Mahmoud M Abdelrazik, Dr principal investigator
Mansoura University
Mahmoud Thabet, D study director
Mansoura University
2 sites 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 and Prednisolone and Clomiphene citrate and folic acid in people with Infertility and Polycystic Ovarian Syndrome, run by Mahmoud Thabet at 2 sites in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 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 Mahmoud M Abdelrazik, Dr (+201005548881, dr_mahmoudhosam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation rate (time frame: 3 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 8 Jan 2019.