Polycystic Ovary SyndromeNCT04021940
Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in PCOS Patients
A study testing ULOD in people with Polycystic Ovary Syndrome, run by Hatem AbuHashim.
Trial summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of infertility in women of reproductive age affecting up to 20% of them. Laparoscopic ovarian drilling (LOD) is considered a second-line treatment of infertile patients with clomiphene citrate-resistant (CCR) PCOS i.e. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- ULOD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2019to 30 Jul 2021
- 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 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of PCOS will be based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS and its modification (ESHRE, 2018).
- CCR will be considered if persistent anovulation with 150 mg CC daily for 5 days per cycle, for at least three cycles.
- Only patients with a phenotype characterized by oligomenorrhoea/anovulation, hyperandrogenaemia and polycystic ovaries on ultrasound examination (PCOM) and a phenotype characterized by oligomenorrhoea/anovulation and PCOM will be enrolled in the study.
- Age: 20-34 years.
- Body mass index < 30 kg/m2
- Patent fallopian tubes by hysterosalpingography.
- Normal semen analysis of husbands.
Who cannot join
- Age ≥ 35 years.
- BMI ≥ 30
- Previous history of LOD
- PCOS phenotypes with regular menses or without PCOM ovaries on USS.
- Other causes of infertility
- Women with adrenal hyperplasia, thyroid disease, Cushing's syndrome, hyperprolactinemia and a tumor-related excess of androgen.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Comparison of Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome Patients
Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of infertility in women of reproductive age affecting up to 20% of them. Laparoscopic ovarian drilling (LOD) is considered a second-line treatment of infertile patients with clomiphene citrate-resistant (CCR) PCOS i.e. those who did not ovulate in response to CC doses of up to 150 mg for at least three consecutive cycles. The advantage of LOD is the induction of unifollicular ovulation without the risk of ovarian hyperstimulation syndrome or high-order multiple pregnancies.
The common practice of LOD was to drill both ovaries i.e. bilateral (BLOD) with a fixed dose of 600 Joules per each ovary (1200 Joules in both) delivered through four punctures, each for 4 s and using 40 W. However, its main adverse effect is diminished ovary reserve due to tissue damage (2). In 1994, Balen and Jacobs reported the effectiveness of fixed-dose unilateral LOD (ULOD) in the management of those women. Subsequently, several randomized trials demonstrated its efficacy with comparable ovulation and pregnancy rates to BLOD.
Recently, a new concept called"dose-adjusted" ULOD was proposed. It means to tailor the energy applied to one ovary, according to its preoperative volume using 60 J/ cm3. When compared with the fixed-dose BLOD among 96 infertile women with CCR- PCOS, a significantly higher ovulation rate during the first postoperative menstrual cycle was in favor of the ULOD group (73 vs. 49%). Meanwhile, a comparable ovulation rate over the 6-month period was found (82 vs. 64%) (6). In addition, both groups experienced a reduction in serum anti-mullerian hormone (AMH) level after LOD which was significantly more in the BLOD group in the first and the 6-month follow-up periods. However, another RCT (n=108 CCR- PCOS patients) reported a comparable ovulation and pregnancy rates at 3-month follow-up period (65.4 vs. 77.3% and 15.4 vs. 26.4%, in ULOD and BLOD respectively) with a reduction in the effectiveness of dose-adjusted ULOD after 6 months. A highly significant difference between ULOD and BLOD groups with regard to the AMH level at 3- and 6-month was also reported. Thereby, the efficacy of dose-adjusted ULOD in improving fertility outcomes in infertile women with CCR- PCOS as well as its effect on ovarian reserve warrants more investigation.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- ULOD
- 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.
ULODProcedure or surgery
ULOD
| Study group | Role | What they receive |
|---|---|---|
| Dose adjusted ULOD | Experimental | dose adjusted ULOD using 60J/cm3 applied to the larger ovary. The number of punctures (Np) per ovary will be calculated according to the following formula: Np = 60 J/cm3 divided by 30 W x 4 s. Receives: Procedure: ULOD |
| Fixed dose ULOD | Active comparator | 600 J for the larger ovary will be delivered through four punctures, each for 4 s and 40 W Receives: Procedure: ULOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovulation rate
serum progesterone level >5 ng/mL on D 21 of the cycle
Measured: At 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start5 Aug 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatem AbuHashim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem AbuHashim, Mansoura University
- Investigators
- Hatem Abu Hashim, MD. FRCOG. PhD, Study chair, Faculty of Medicine, Mansoura UniversityEman Lotfy, MBBCh, Principal investigator, New Mansoura General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021940
- Sponsor's protocol ID
- MS.19.05.615
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abu Hashim H, Foda O, El Rakhawy M. Unilateral or bilateral laparoscopic ovarian drilling in polycystic ovary syndrome: a meta-analysis of randomized trials. Arch Gynecol Obstet. 2018 Apr;297(4):859-870. doi: 10.1007/s00404-018-4680-1. Epub 2018 Jan 27.
PubMed 29374790
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome Patients
- ClinicalTrials.gov ID
- NCT04021940
- Acronym / sponsor ID
- MS.19.05.615
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hatem AbuHashimUniversity, hospital or other
- Study start
- 5 Aug 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 16 Jul 2019 (actual)
- 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.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of infertility in women of reproductive age affecting up to 20% of them. Laparoscopic ovarian drilling (LOD) is considered a second-line treatment of infertile patients with clomiphene citrate-resistant (CCR) PCOS i.e. those who did not ovulate in response to CC doses of up to 150 mg for at least three consecutive cycles. The advantage of LOD is the induction of unifollicular ovulation without the risk of ovarian hyperstimulation syndrome or high-order multiple pregnancies.
The common practice of LOD was to drill both ovaries i.e. bilateral (BLOD) with a fixed dose of 600 Joules per each ovary (1200 Joules in both) delivered through four punctures, each for 4 s and using 40 W. However, its main adverse effect is diminished ovary reserve due to tissue damage (2). In 1994, Balen and Jacobs reported the effectiveness of fixed-dose unilateral LOD (ULOD) in the management of those women. Subsequently, several randomized trials demonstrated its efficacy with comparable ovulation and pregnancy rates to BLOD.
Recently, a new concept called"dose-adjusted" ULOD was proposed. It means to tailor the energy applied to one ovary, according to its preoperative volume using 60 J/ cm3. When compared with the fixed-dose BLOD among 96 infertile women with CCR- PCOS, a significantly higher ovulation rate during the first postoperative menstrual cycle was in favor of the ULOD group (73 vs. 49%). Meanwhile, a comparable ovulation rate over the 6-month period was found (82 vs. 64%) (6). In addition, both groups experienced a reduction in serum anti-mullerian hormone (AMH) level after LOD which was significantly more in the BLOD group in the first and the 6-month follow-up periods. However, another RCT (n=108 CCR- PCOS patients) reported a comparable ovulation and pregnancy rates at 3-month follow-up period (65.4 vs. 77.3% and 15.4 vs. 26.4%, in ULOD and BLOD respectively) with a reduction in the effectiveness of dose-adjusted ULOD after 6 months. A highly significant difference between ULOD and BLOD groups with regard to the AMH level at 3- and 6-month was also reported. Thereby, the efficacy of dose-adjusted ULOD in improving fertility outcomes in infertile women with CCR- PCOS as well as its effect on ovarian reserve warrants more investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose adjusted ULOD | Experimental | Procedure: ULODdose adjusted ULOD using 60J/cm3 applied to the larger ovary. The number of punctures (Np) per ovary will be calculated according to the following formula: Np = 60 J/cm3 divided by 30 W x 4 s. |
| Fixed dose ULOD | Active comparator | Procedure: ULOD600 J for the larger ovary will be delivered through four punctures, each for 4 s and 40 W |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of PCOS will be based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS and its modification (ESHRE, 2018).
- CCR will be considered if persistent anovulation with 150 mg CC daily for 5 days per cycle, for at least three cycles.
- Only patients with a phenotype characterized by oligomenorrhoea/anovulation, hyperandrogenaemia and polycystic ovaries on ultrasound examination (PCOM) and a phenotype characterized by oligomenorrhoea/anovulation and PCOM will be enrolled in the study.
- Age: 20-34 years.
- Body mass index < 30 kg/m2
Key exclusion criteria (6 listed)
- Age ≥ 35 years.
- BMI ≥ 30
- Previous history of LOD
- PCOS phenotypes with regular menses or without PCOM ovaries on USS.
- Other causes of infertility
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 |
|---|---|---|
| ULODULOD | Procedure or surgery | Dose adjusted ULOD, Fixed dose ULOD |
Primary outcome
ovulation rate
Time frame: At 6 months postoperative
serum progesterone level >5 ng/mL on D 21 of the cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 29374790Abu Hashim H, Foda O, El Rakhawy M. Unilateral or bilateral laparoscopic ovarian drilling in polycystic ovary syndrome: a meta-analysis of randomized trials. Arch Gynecol Obstet. 2018 Apr;297(4):859-870. doi: 10.1007/s00404-018-4680-1. Epub 2018 Jan 27.
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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. FRCOG. PhD study chair
Faculty of Medicine, Mansoura University
Eman Lotfy, MBBCh principal investigator
New Mansoura General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ULOD in people with Polycystic Ovary Syndrome, run by Hatem AbuHashim.
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 7 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 19 Jul 2019. 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.
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 Hatem Abu Hashim, MD. FRCOG.PhD (+20502300002, hatem_ah@hotmail.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: At 6 months postoperative). 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 NCT04021940, which also lists 1 linked publication.
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 19 Jul 2019.