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OpenTrials
Completed

NCT Number: NCT03358199

LOD Before IVF/ICSI in PCOS Patients With High AMH

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

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Key information

Conditions

Infertility Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovarian Syndrome Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

LOD

Procedure

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

Other names: Laparoscopic ovarian drilling

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 36-38 hours after triggering of oocyte maturation

    Number of collected oocytes during oocyte retrieval

  2. Oocyte maturity rate

    Time frame: Within one hour after oocyte retrieval

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

  3. Fertilization rate

    Time frame: 20-24 hours after injection (or insemination)

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

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 6 weeks after embryo transfer

    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

  2. Implantation rate

    Time frame: 6 weeks after embryo transfer

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

  3. Incidence of early OHSS

    Time frame: Within 9 days of final triggering of oocyte maturation

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2017
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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