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Polycystic Ovary SyndromePCOSNCT03334955

Laparoscopic Ovarian Drilling and Subendometrial Blood Flow

A study testing Laparoscopic ovarian drilling in people with Polycystic Ovary Syndrome, run by Zagazig University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Serum level of total testosterone was measured in the early follicular phase (days 2-4 of spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg daily for 5 days) to induce withdrawal bleeding… 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?
Laparoscopic ovarian drilling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
15 Jul 2016to 30 Oct 2017
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

  • Patients' ages 20 to 34 years.
  • BMI 18-25 kg/m2.
  • PCOS was diagnosed according to Rotterdam criteria, 2003 (two criteria are sufficient for diagnosis of PCOS): (i) oligo-and/or an-ovulation; which is manifested clinically by amenorrhoea or oligomenorrhoea, (ii) hyperandrogenism (clinical and/or biochemical); (hirsutism and/or elevated serum level of total testosterone), (iii) polycystic ovaries by ultrasound (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml), ( we included only patients who had the three criteria of PCOS) , and previously documented anovulation by transvaginal ultrasound follicular monitoring while taking incremental doses of clomiphene citrate (clomiphene citrate resistant).
  • Hysterosalpingography and husband semen analysis were normal in all subjects.
  • All women in the study were free of any medical illness and had not received any medications in the last 6-9 months before the study apart from clomiphene citrate.

Who cannot join

  • Other PCOS like syndromes (late onset congenital adrenal hyperplasia-androgen producing tumors-Cushing,s syndrome), hyperprolactinemia and thyroid abnormalities.
  • Gross ovarian pathology either diagnosed preoperatively by ultrasound or intraoperatively by laparoscopy.
  • Any uterine pathology diagnosed preoperatively by ultrasound, HSG or hysteroscopy; or intraoperatively by endoscopy and suspected to cause infertility.
  • Other causes of infertility even if diagnosed during laparoscopy such as tubal pathology and pelvic endometriosis or adhesions.
  • Previous uterine, tubal or ovarian surgery.
  • Contraindications to laparoscopy and general anesthesia.
  • Pregnancy before the first post-operative menstrual cycle.

About this study

Official title: Effect of Laparoscopic Ovarian Drilling on Subendometrial Blood Flow in Women With Polycystic Ovary Syndrome

Serum level of total testosterone was measured in the early follicular phase (days 2-4 of spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg daily for 5 days) to induce withdrawal bleeding and total testosterone was measured in days 2-4 of this withdrawal bleeding.

Color Doppler ultrasound scanning will be performed to assess the subendometrial blood flow. The subendometrial region was observed and analyzed in each woman using color and power Doppler flow ultrasonography. By means of color and power Doppler flow imaging, color signals was searched for in the subendometrial region and areas of maximum color intensity, representing the greatest Doppler frequency shifts, was visualized, then selected for pulsed Doppler examination. Pulsatility index (PI) and resistance index (RI) were calculated in each selected Doppler wave.

Read more

Laparoscopic ovarian drilling was performed under general anesthesia with good muscle relaxation and endotracheal intubation using the three-punctures technique (one puncture 10mm at the umbilicus and the other two punctures 5mm at both iliac fossa) in the early follicular phase (after stoppage of menstrual or withdrawal bleeding).

A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points (regardless of the size of the ovary), with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds. The ovary was then cooled using 200 ml crystalloid solution before releasing the ligament.

Follow up:

Total testosterone and blood flow assessment (PI - RI) of the subendometrial region were performed again in the early follicular phase (days 2-4 of the menstrual cycle) of the first post-operative spontaneous menstruation (which occurred within 10 weeks after the operation).

Also, patients were followed to detect ovulation. ovulating patients were followed for 6 months to detect pregnancy.

Read the detailed description

Effect of Laparoscopic Ovarian Drilling on Subendometrial Blood Flow in Women with Polycystic Ovary Syndrome

Patients and methods:

This interventional study was carried out in the Department of Obstetrics and Gynecology (Infertility, Ultrasound and Gynecologic endoscopy units), Faculty of Medicine, Zagazig University Hospitals in the period between July 2016 and October 2017. The study included 200 infertile women (primary or secondary infertility) with PCOS attended the infertility outpatient clinic and fulfilled the following inclusion criteria: 1- Patients' ages 20 to 34 years; 2- BMI 18-25 kg/m2; 3- PCOS was diagnosed according to Rotterdam criteria, 2003 (two criteria are sufficient for diagnosis of PCOS): (i) oligo-and/or an-ovulation; which is manifested clinically by amenorrhoea or oligomenorrhoea, (ii) hyperandrogenism (clinical and/or biochemical); (hirsutism and/or elevated serum level of total testosterone), (iii) polycystic ovaries by ultrasound (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml), ( we included only patients who had the three criteria of PCOS) , and previously documented anovulation by transvaginal ultrasound follicular monitoring while taking incremental doses of clomiphene citrate (clomiphene citrate resistant); 4- Hysterosalpingography and husband semen analysis were normal in all subjects. 5- All women in the study were free of any medical illness and had not received any medications in the last 6-9 months before the study apart from clomiphene citrate.

Exclusion criteria were: 1- Other PCOS like syndromes (late onset congenital adrenal hyperplasia-androgen producing tumors-Cushing,s syndrome), hyperprolactinemia and thyroid abnormalities; 2- Gross ovarian pathology either diagnosed preoperatively by ultrasound or intraoperatively by laparoscopy; 3- Any uterine pathology diagnosed preoperatively by ultrasound, HSG or hysteroscopy; or intraoperatively by endoscopy and suspected to cause infertility; 3- Other causes of infertility even if diagnosed during laparoscopy such as tubal pathology and pelvic endometriosis or adhesions; 4- Previous uterine, tubal or ovarian surgery. 5- Contraindications to laparoscopy and general anesthesia; 6- Pregnancy before the first post-operative menstrual cycle.

After full detailed history taking, general, abdominal and local examination and exclusion of any associated medical disorders, transabdominal and/or transvaginal ultrasound was done to exclude patients with ovarian or pelvi-abdominal masses. Other investigations were done to fulfill the inclusion and exclusion criteria (serum prolactin level, free T3, free T4, TSH). Serum level of total testosterone was measured in the early follicular phase (days 2-4 of spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg daily for 5 days) to induce withdrawal bleeding and total testosterone was measured in days 2-4 of this withdrawal bleeding. Total testosterone was done for all patients in the Laboratory of Zagazig University Hospitals by Electrochemiluminescence (ECL) technology (Cobas e 411 analyzer-Roche Diagnostics GmbH-D-68298 Mannheim-Germany).

Transvaginal 2D color Doppler probe of Voluson 730 pro V machine (GE healthcare, Austria with a 3.5 MHz sector transducer for TAS and 7.5 MHz sector transducer for TVS) was used. While the patients in lithotomy position after evacuation of their urinary bladder and on the same days of total testosterone level assay, baseline 2D TVS was used to examine the uterus for any abnormality and measuring the uterine size and endometrial thickness and then to identify PCO criteria in both ovaries and ovarian volume was measured using ellipisoid prolate formulae (length X width X height X 0.523, which is calculated automatically by the software of the ultrasound machine), (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml) then color Doppler ultrasound scanning will be performed to assess the subendometrial blood flow. The subendometrial region was observed and analyzed in each woman using color and power Doppler flow ultrasonography. By means of color and power Doppler flow imaging, color signals was searched for in the subendometrial region and areas of maximum color intensity, representing the greatest Doppler frequency shifts, was visualized, then selected for pulsed Doppler examination. Pulsatility index (PI) and resistance index (RI) were calculated in each selected Doppler wave.

Laparoscopic ovarian drilling was performed under general anesthesia with good muscle relaxation and endotracheal intubation using the three-punctures technique (one puncture 10mm at the umbilicus and the other two punctures 5mm at both iliac fossa) in the early follicular phase (after stoppage of menstrual or withdrawal bleeding). The zero-degree telescope (Karl Storz, Tuttlingen, Germany) was introduced to visualize the peritoneal cavity. The pelvis was thoroughly inspected for any pathology and the ovaries were examined for the features of polycystic ovary (bilateral ovarian enlargement with smooth glistening surface unbroken by the usual wrinkles and thick, smooth, whitish capsule). Methylene blue test was done for all patients to examine the tubal patency and bilateral tubal patency is mandatory before ovarian drilling.

A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points (regardless of the size of the ovary), with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds. The ovary was then cooled using 200 ml crystalloid solution before releasing the ligament.

Follow up:

Total testosterone and blood flow assessment (PI - RI) of the subendometrial region were performed again in the early follicular phase (days 2-4 of the menstrual cycle) of the first post-operative spontaneous menstruation (which occurred within 10 weeks after the operation). In non-menstruating patients, total testosterone and the blood flow assessment were performed by the end of the 10 weeks. In menstruating patients, this cycle was monitored to detect ovulation. Ovulation was assessed by serial transvaginal ultrasound until visualization of pre-ovulatory follicle of at least 18 mm. Ovulation was confirmed by seeing follicle collapse on subsequent transvaginal ultrasound, appearance of fluid in the Cul-de-sac and elevated mid-luteal serum progesterone level >5 ng/ml. Ovulating group was informed to report the occurrence of natural conception for 6 months after LOD. Pregnancy was diagnosed by positive pregnancy test with seeing intrauterine gestational sac by transvaginal ultrasound.

Patients who did not menstruate (pregnancy was excluded at first) or did not ovulate within 10 weeks after drilling as evidenced by poor or no follicular growth by serial transvaginal ultrasound folliculometry, and low mid-luteal serum progesterone level < 5 ng/ml were referred to another group of researchers for re-evaluation

Being tested
Laparoscopic ovarian drilling
Keywords
Polycystic Ovary Syndrome, Laparoscopic ovarian drilling, subendometrial blood flow
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.

  • Laparoscopic ovarian drillingProcedure or surgery

    A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points, with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds.

Study groups in NCT03334955
Study groupRoleWhat they receive
polycystic ovary syndrome patientsExperimentalpatients with polycystic ovary syndrome performed laparoscopic ovarian drilling to induce ovulation
Receives: Procedure: Laparoscopic ovarian drilling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subendometrial blood flow

    change in Subendometrial blood flow after laparoscopic ovarian drilling

    Measured: Within 10 weeks

Secondary outcomes (2)
  1. Ovulation

    Ovulation was assessed by serial transvaginal ultrasound until visualization of pre-ovulatory follicle of at least 18 mm. Ovulation was confirmed by seeing follicle collapse on subsequent transvaginal ultrasound, appearance of fluid in the Cul-de-sac and elevated mid-luteal serum progesterone level >5 ng/ml.

    Measured: Within 10 weeks

  2. Pregnancy

    Ovulating group was informed to report the occurrence of natural conception for 6 months after LOD. Pregnancy was diagnosed by positive pregnancy test with seeing intrauterine gestational sac by transvaginal ultrasound.

    Measured: Within 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start15 Jul 2016
  3. Primary completion15 Mar 2017
  4. Study completion30 Oct 2017

Resources

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
Not applicable
Intervention model
Single group
Model description
Laparoscopic ovarian drilling was performed under general anesthesia with good muscle relaxation and endotracheal intubation using the three-punctures technique (one puncture 10mm at the umbilicus and the other two punctures 5mm at both iliac fossa) in the early follicular phase. A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points (regardless of the size of the ovary), with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds. The ovary was then cooled using 200 ml crystalloid solution before releasing the ligament.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03334955
Sponsor's protocol ID
ZU-IRB#: 2774/11-72016
Acronym
PCOS
Status last verified
Nov 2017
First submitted
2 Nov 2017
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic ovarian drilling in people with Polycystic Ovary Syndrome, run by Zagazig University.

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 5 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: finished, as of the sponsor's last update on 7 Nov 2017. 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?

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?

Subendometrial blood flow (time frame: Within 10 weeks). 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 7 Nov 2017.

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