InfertilityPhase 4ESLODNCT02140398
Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women
A Phase 4 study testing Endometrial Currettage in people with Infertility and Polycystic Ovarian Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovarian Syndrome
- What is being tested?
- Endometrial Currettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Oct 2015
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
- Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
- Patent Fallopian tubes as confirmed by hysterosalpingography
- Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).
Who cannot join
- women with BMI >30,
- age < 18 years or > 39 years,
- women with ovarian cysts identified by transvaginal ultrasound
- male factor infertility
- Tubal factor infertility as suggested by hystrosalpingogram (HSG)
- Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Teaching Hospital
Al Mansurah, 53111
Ahmed Gibreel, MD
About this study
Official title: Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.
Read the detailed description
Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Being tested
- Endometrial Currettage
- Keywords
- infertility, PCOS, scratching, endometrial receptivity
- 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.
Endometrial CurrettageProcedure or surgery
Also called Endometrial injury, endometrial scratching, Endometrial scraping
Only Laparoscopic ovarian drilling without endometrial currettage will be performed
| Study group | Role | What they receive |
|---|---|---|
| Currettage | Experimental | Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling Receives: Procedure: Endometrial Currettage |
| Nothing | No intervention | No endometrial curettage at time of Laparoscopic ovarian drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate per woman randomized
Measured: 15 months
Secondary outcomes (1)
pregnancy rate per woman randomised
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 posted16 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 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.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gibreel, Mansoura University
- Investigators
- Ahmed Gibreel, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140398
- Sponsor's protocol ID
- 92013
- Acronym
- ESLOD
- Status last verified
- May 2014
- First submitted
- 25 Apr 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02140398
- Acronym / sponsor ID
- ESLOD / 92013
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Keywords
- infertility, PCOS, scratching, endometrial receptivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 16 May 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.
Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.
Detailed description
Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Currettage | Experimental | Procedure: Endometrial CurrettageEndometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling |
| Nothing | No intervention | –No endometrial curettage at time of Laparoscopic ovarian drilling |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
- Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
- Patent Fallopian tubes as confirmed by hysterosalpingography
- Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).
Key exclusion criteria (6 listed)
- women with BMI >30,
- age < 18 years or > 39 years,
- women with ovarian cysts identified by transvaginal ultrasound
- male factor infertility
- Tubal factor infertility as suggested by hystrosalpingogram (HSG)
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 |
|---|---|---|
| Endometrial CurrettageAlso: Endometrial injury, endometrial scratching, Endometrial scrapingOnly Laparoscopic ovarian drilling without endometrial currettage will be performed | Procedure or surgery | Currettage |
Primary outcome
live birth rate per woman randomized
Time frame: 15 months
1 secondary outcome
pregnancy rate per woman randomised
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 16 May 2014.
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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 Gibreel, MD principal investigator
Mansoura University
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 Endometrial Currettage in people with Infertility and Polycystic Ovarian Syndrome, run by Mansoura University at 1 site 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 4 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 16 May 2014. 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 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 Ahmed Gibreel, MD (00201004045733, ahmedfathgi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate per woman randomized (time frame: 15 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 16 May 2014.