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InfertilityNCT03358199

LOD Before IVF/ICSI in PCOS Patients With High AMH

An observational study of Infertility and Polycystic Ovarian Syndrome, run by Mansoura University at 1 site in Egypt.

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

To evaluate the effect of performing laparoscopic ovarian drilling (LOD) before proceeding to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) on the cycle outcomes in polycystic ovarian syndrome (PCOS) patients with high antimullerian hormone (AMH) levels Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Infertility, Polycystic Ovarian Syndrome
What is being tested?
LOD
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteEgypt
Study dates
22 Mar 2013to 18 Jun 2017
Phase
Observational
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 35 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Fertility care clinic

Who may be able to join

  • PCOS women subjected to COS through fixed gonadotropin releasing hormone (GnRH) antagonist protocol with final triggering of oocyte maturation by GnRH agonist (GnRHa)
  • Elevated serum AMH level (≥ 7 ng/ml)

Who cannot join

  • Age < 18 years or > 35 years
  • Body mass index (BMI) < 19 kg/m2 or > 35 kg/m2
  • Use of cabergoline therapy or coasting to minimize the risk of OHSS

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Fertility Care Unit (FCU) in Mansoura University Hospital

    Al Mansurah, Dakahlia Governorate, 35111

Other trials in Egypt

About this study

Official title: Laparoscopic Ovarian Drilling Before IVF/ICSI in Polycystic Ovarian Syndrome Patients With High Antimullarian Hormone

To evaluate the effect of performing laparoscopic ovarian drilling (LOD) before proceeding to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) on the cycle outcomes in polycystic ovarian syndrome (PCOS) patients with high antimullerian hormone (AMH) levels

Read the detailed description

Retrospective case-control study of PCOS women with high serum AMH level (≥ 7 ng/ml) who were subjected IVF/ICSI. Women underwent LOD in the preceding 3 months prior to IVF/ICSI (study group) will be compared with a control group of women who did not underwent LOD (control group)

Being tested
LOD
Keywords
LOD, PCOS, AMH, OHSS
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.

  • LODProcedure or surgery

    Also called Laparoscopic ovarian drilling

    Women underwent LOD in the preceding 3 months prior to IVF/ICSI

Study groups in NCT03358199
Study groupRoleWhat they receive
Study groupPCOS women with AMH level (≥ 7 ng/ml) who underwent LOD in the preceding 3 months prior to IVF/ICSI
Receives: Procedure: LOD
Control groupPCOS women with AMH level (≥ 7 ng/ml) who did not undergo LOD in the preceding 3 months prior to IVF/ICSI

What is being measured

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

  1. Number of oocytes retrieved

    Number of collected oocytes during oocyte retrieval

    Measured: 36-38 hours after triggering of oocyte maturation

  2. Oocyte maturity rate

    Calculated for each woman by dividing the number of mature oocytes (MII oocytes) by the total number of oocytes retrieved

    Measured: Within one hour after oocyte retrieval

  3. Fertilization rate

    Calculated for each couple by dividing the number of fertilized oocytes by the number of injected (or inseminated) oocytes

    Measured: 20-24 hours after injection (or insemination)

Secondary outcomes (3)

  1. Clinical pregnancy rate

    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

    Measured: 6 weeks after embryo transfer

  2. Implantation rate

    Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

    Measured: 6 weeks after embryo transfer

  3. Incidence of early OHSS

    Incidence of OHSS within 9 days of final triggering of oocyte maturation

    Measured: Within 9 days of final triggering of oocyte maturation

Timeline

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

  1. First posted30 Nov 2017
  2. Study start22 Mar 2013
  3. Primary completion31 May 2017
  4. Study completion18 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03358199
Sponsor's protocol ID
MSA6
Status last verified
Nov 2017
First submitted
27 Nov 2017
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of 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 2 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 2 Dec 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.

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?

Number of oocytes retrieved (time frame: 36-38 hours after triggering of oocyte maturation). The study lists 3 primary outcomes in all. 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 NCT03358199.

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 Dec 2017.

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