InfertilityPhase 4NCT02186782
Concomitant CC and E2 Versus CC Alone in Ovulation Induction
A Phase 4 study testing Clomiphene citrate and Estradiol in people with Infertility and Anovulation, run by Maher elesawi kamel elesawi at 3 sites in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility, Anovulation
- What is being tested?
- Clomiphene citrate and Estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 3 sitesEgypt
- Study dates
- Jun 2014to Aug 2018
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women with eugonadotrophic anovulation/oligoovulation.
- Unexplained infertility.
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 anovulation/oligoovulation.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Metabolic or hormonal abnormalities.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
- Recruiting
Private practice settings
Al Mansurah, Dakahlia Governorate
Ahmed M Badawy, Prof, +201282848485, ambadawy@yahoo.com
Ahmed M Badaway, Prof
- Recruiting
Private practice settings
Mīt Ghamr, Dakahlia Governorate
Maher E Kamel Elesawi, Dr, +20104523494, maherelesawi@yahoo.com
Maher E Kamel Elesawi, Dr
About this study
Official title: Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial
The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.
Read the detailed description
Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of 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 midluteal 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, Anovulation
- Being tested
- Clomiphene citrate and Estradiol, Clomiphene citrate and Placebo
- Keywords
- Clomiphene citrate, Estradiol, Endometrial thickness
- Medical subject headings
- Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrate and EstradiolDrug
Also called Clomid and Estradiol valerate
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)
Clomiphene citrate and PlaceboDrug
Also called Clomid and Placebo
Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate-Estradiol group | Active comparator | Women will receive clomiphene citrate and estradiol Receives: Drug: Clomiphene citrate and Estradiol |
| Clomiphene citrate group | Active comparator | Women will receive clomiphene citrate and placebo Receives: Drug: Clomiphene citrate and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
Endometrial thickness on day of HCG administration
Endometrial thickness by TVS on day of HCG administration
Measured: 3 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 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maher elesawi kamel elesawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maher elesawi kamel elesawi, Mansoura University
- Investigators
- Ahmed M Badawy, Prof, Principal investigator, Mansoura UniversityMaher E Kamel Elesawi, Dr, Study director, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186782
- Sponsor's protocol ID
- ME1
- Status last verified
- Mar 2017
- First submitted
- 28 Jun 2014
- Last updated
- 22 Mar 2017
- 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 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02186782
- Acronym / sponsor ID
- ME1
- Conditions
- Infertility, Anovulation
- Keywords
- Clomiphene citrate, Estradiol, Endometrial thickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Maher elesawi kamel elesawiUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 10 Jul 2014 (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 estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.
Detailed description
Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of 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 midluteal 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate-Estradiol group | Active comparator | Drug: Clomiphene citrate and EstradiolWomen will receive clomiphene citrate and estradiol |
| Clomiphene citrate group | Active comparator | Drug: Clomiphene citrate and PlaceboWomen will receive clomiphene citrate and placebo |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile women with eugonadotrophic anovulation/oligoovulation.
- Unexplained infertility.
Key exclusion criteria (6 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 anovulation/oligoovulation.
- 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 EstradiolAlso: Clomid and Estradiol valerateWomen will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle) | Drug | Clomiphene citrate-Estradiol group |
| Clomiphene citrate and PlaceboAlso: Clomid and PlaceboWomen will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle) | Drug | Clomiphene citrate group |
Primary outcome
Clinical pregnancy rate
Time frame: 6-8 weeks gestational age
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
1 secondary outcome
Endometrial thickness on day of HCG administration
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- 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.
Ahmed M Badawy, Prof principal investigator
Mansoura University
Maher E Kamel Elesawi, Dr study director
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
3 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 Estradiol in people with Infertility and Anovulation, run by Maher elesawi kamel elesawi at 3 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 6 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Maher E Kamel Elesawi, Dr (+201016103662, maherelesawi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 6-8 weeks gestational age). 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 22 Mar 2017.