Polycystic Ovary SyndromePhase 2NCT03237312
Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome
A Phase 2 study testing Laparoscopic ovarian drilling and Antimullerian hormone in people with Polycystic Ovary Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Laparoscopic ovarian drilling and Antimullerian hormone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 30 Nov 2016
- Phase
- Phase 2
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility more than 2 years.
- Age between 20-35 years.
- clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.
- No contraindications for laparoscopy.
- Normal Hysterosalpingography
Who cannot join
- Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect….
- Women's age less than 20 years or more than 35 years.
- Previous Laparoscopic surgery.
- Previous ovarian surgery.
- Women with Antimullerian hormone level less than 4 ng/ml.
- Tubal factor infertility as diagnosed by Hysterosalpingography .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome
In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Laparoscopic ovarian drilling, Antimullerian hormone
- 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
The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.
Antimullerian hormoneBiological
- In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.
- In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.
| Study group | Role | What they receive |
|---|---|---|
| The control group | Other | Four punctures in each ovary were done regardless of the level of antimullerian hormone Receives: Procedure: Laparoscopic ovarian drilling; Biological: Antimullerian hormone |
| The study group | Other | The number of ovarian drills was adjusted according to antimullerian hormone level Receives: Procedure: Laparoscopic ovarian drilling; Biological: Antimullerian hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of ovarian follicle (mm)
Measured: 14 days
Secondary outcomes (2)
Antimullerian hormone level (ng/dl)
Measured: 3 months
Ovarian volume (ml)
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 posted2 Aug 2017
- Study start1 Jan 2015
- Primary completion30 Sep 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237312
- Sponsor's protocol ID
- AMH-PCOS
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT03237312
- Acronym / sponsor ID
- AMH-PCOS
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 2 Aug 2017 (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.
In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Other | Procedure: Laparoscopic ovarian drilling, Biological: Antimullerian hormoneFour punctures in each ovary were done regardless of the level of antimullerian hormone |
| The study group | Other | Procedure: Laparoscopic ovarian drilling, Biological: Antimullerian hormoneThe number of ovarian drills was adjusted according to antimullerian hormone level |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Infertility more than 2 years.
- Age between 20-35 years.
- clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.
- No contraindications for laparoscopy.
- Normal Hysterosalpingography
Key exclusion criteria (6 listed)
- Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect….
- Women's age less than 20 years or more than 35 years.
- Previous Laparoscopic surgery.
- Previous ovarian surgery.
- Women with Antimullerian hormone level less than 4 ng/ml.
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 |
|---|---|---|
| Laparoscopic ovarian drillingThe electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions. | Procedure or surgery | The control group, The study group |
| Antimullerian hormone1. In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed. 2. In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed. | Biological | The control group, The study group |
Primary outcome
Size of ovarian follicle (mm)
Time frame: 14 days
2 secondary outcomes
Antimullerian hormone level (ng/dl)
Time frame: 3 months
Ovarian volume (ml)
Time frame: 3 months
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 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic ovarian drilling and Antimullerian hormone in people with Polycystic Ovary Syndrome, run by Assiut 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 5 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: finished, as of the sponsor's last update on 2 Aug 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Size of ovarian follicle (mm) (time frame: 14 days). 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 2 Aug 2017.