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Completed

NCT Number: NCT01984320

Cabergoline and Coasting to Prevent OHSS

The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.

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Key information

Conditions

OHSS

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, Egypt

About this study

To randomly compare three study groups under a high risk of developing OHSS to one of three arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long luteal GnRH agonist protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age <or= 35, BMI <or= 30
  • Long protocol GnRH agonist cycles
  • Estradiol level on day of HCG >or= 3500 pg/ml
  • Retrieving more than 15 oocytes

Exclusion criteria

  • Male factor
  • Uterine factor

Treatment and study plan

ICSI

Procedure

Long luteal GnRH agonist protocol: patients will receive GnRH agonist from day 21 of the previous cycle of stimulation and then on day 3 of the stimulation cycle they will start hMG injections with 225 IU/day. Folliculometry will start on day 6 stimulation by vaginal ultrasound. Estradiol levels will be measured on day 8, 10 and 12 of stimulation if appropriate. According to ultrasound and estradiol level patients will be randomized to either one of the study arms. When ready final triggering will be done by human chorionic gonadotropin (10000 IU) and oocyte collection is done at 36 hour from triggering. Embryo transfer is then done 3 days afterwards with ultrasound guidance.

Primary outcomes

  1. Rate and degree of OHSS (composite outcome)

    Time frame: 14 days

    Symptoms of nausea, vomiting, shortness of breath, abdominal pain,abdominal distension. Ovarian size and fluid in douglas pouch by ultrasound. Haematocrit, total leucocytic count, creatinine and Estradiol level as biochemical markers. Early OHSS first 9 days after ovum pickup and late is after 9 days till 14 days (time of pregnancy test)

Secondary outcomes

  1. Number of oocytes

    Time frame: 1 day

    Number of oocytes collected on the day of oocyte collection

Other outcomes

  1. Number of Metaphase II (MII) oocytes

    Time frame: 1 day

    Number of MII oocytes collected on the day of oocyte collection

  2. Fertilization rate

    Time frame: 2 days

    Number of embryos that show signs of fertilization in each patient

  3. Number of embryos

    Time frame: 3 to 5 days

    Number of embryos assessed for embryo transfer in each patient

  4. Implantation rate

    Time frame: 5 weeks

    the ratio of the number of gestational sacs to the number of embryos transferred

  5. Chemical pregnancy rate

    Time frame: 14 days

    The patients who have a positive quantitative Beta human chorionic gonadotrophin (BHCG) and do not continue their pregnancy with a drop in the result and start of menstruation

  6. Clinical pregnancy rate

    Time frame: 28 days

    patients who show an intra-uterine gestational sac with positive fetal pulsations on ultrasound 14 days after their pregnancy test

  7. Early miscarriage rate

    Time frame: 12 weeks

    pregnancy loss in the first 12 weeks of gestation

  8. Ongoing pregnancy rate

    Time frame: 12 weeks

    pregnancies going beyond 12 weeks of gestation

  9. Live birth rate

    Time frame: 40 weeks

    live births occuring

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Combining Cabergoline and Coasting in Gonadotropin Releasing Hormone(GnRH)Agonist Protocol in Intracytoplasmic Sperm Injection (ICSI) to Prevent Ovarian Hyperstimulation Syndrome (OHSS): a Randomized Clinical Trial

Acronym: OHSS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2013
Registry last updated
Aug 14, 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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