Polycystic Ovary SyndromeNCT00956267
Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.
A study testing Letrozole and Laparoscopic ovarian diathermy (LOD) in people with Polycystic Ovary Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Letrozole and Laparoscopic ovarian diathermy (LOD)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2006to Mar 2009
- Phase
- Interventional
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- CC resistant PCOS
Who cannot join
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
Read the detailed description
In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Letrozole, Laparoscopic ovarian diathermy (LOD)
- Keywords
- Polycystic ovary syndrome, clomiphene resistance, letrozole, Laparoscopic ovarian diathermy
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles
Laparoscopic ovarian diathermy (LOD)Procedure or surgery
Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | 2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles Receives: Drug: Letrozole |
| Laparoscopic ovarian diathermy (LOD) | Active comparator | Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle. Receives: Procedure: Laparoscopic ovarian diathermy (LOD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary outcomes (1)
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startAug 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Hatem Abu Hashim, MD. MRCOG, Principal investigator, Mansoura University HospitalAbdel Maged Mashaly, MD, Study director, Mansoura University HospitalAhmed Badawy, MD.PhD., Study chair, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956267
- Sponsor's protocol ID
- MU- 094
- Other IDs
- FMH-052-K
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
PubMed 16595197Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192. doi: 10.1136/bmj.328.7433.192.
PubMed 14739186Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3.
PubMed 17636653
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00956267
- Acronym / sponsor ID
- MU- 094
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, clomiphene resistance, letrozole, Laparoscopic ovarian diathermy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Aug 2009 (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 compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.
Detailed description
In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles |
| Laparoscopic ovarian diathermy (LOD) | Active comparator | Procedure: Laparoscopic ovarian diathermy (LOD)Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle. |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CC resistant PCOS
Key exclusion criteria (3 listed)
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
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 |
|---|---|---|
| Letrozole2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles | Drug | Letrozole |
| Laparoscopic ovarian diathermy (LOD)Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle. | Procedure or surgery | Laparoscopic ovarian diathermy (LOD) |
Primary outcome
occurrence of ovulation and midcycle endometrial thickness (mm).
1 secondary outcome
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
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 11 Aug 2009.
- Background: PubMed 16595197Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
- Background: PubMed 14739186Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192. doi: 10.1136/bmj.328.7433.192.
- Background: PubMed 17636653Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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.
Hatem Abu Hashim, MD. MRCOG principal investigator
Mansoura University Hospital
Abdel Maged Mashaly, MD study director
Mansoura University Hospital
Ahmed Badawy, MD.PhD. study chair
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole and Laparoscopic ovarian diathermy (LOD) in people with Polycystic Ovary 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 1 inclusion and 3 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 11 Aug 2009. 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.
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?
occurrence of ovulation and midcycle endometrial thickness (mm).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00956267, which also lists 3 linked publications.
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 11 Aug 2009.