Effect of Cabergoline on Subendometrial Vascularity During ICSI Cycles and Pregnancy Outcome
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Pregnancy rate (chemical , clinical).
Study Overview
Brief Summary
The purpose of this study is to determine the effect of giving cabergoline to patients at risk of OHSS (ovarian hyperstimulation syndrome) after ovum pick up, on endometrial vascularity and it's effect on pregnancy outcome
Detailed Description
Following ethical approval of the committee of obstetrics & gynecology IVF department of kasr al-Aini hospital Cairo University, 150 women attending the IVF unit of Kasr el Aini hospital for management of infertility will be included in the study after obtaining informed consent from each patient. All women are scheduled for intracytoplasmatic sperm injection (ICSI) after controlled ovarian stimulation.
All women included in the study, after applying eligibility criteria , will be subjected to careful history taking and general and local examination, follicle stimulating hormone (FSH), luteinizing hormone (LH), Antral follicle count (AFC) &Antimullerian hormone (AMH) will be recorded and body mass index (BMI) calculation is done.
BMI is defined as weight in kilograms divided by height in meters squared (kg/m2), Excess weight is BMI ≥ 25 kg/m2 and obesity is BMI ≥ 30 kg/m2.
As most patients needing cabergoline for prevention of hyperstimulation are obese, therefore only those with BMI ≥ 30 kg/m2 will be included in the study. The study will include three groups, each group containing 50 patients.
Group A will include patients at risk of OHSS receiving Cabergoline 0.5mg daily for 8 days (Dostinex®, Pfizer Australia Pty Ltd ) from the day of oocyte pick up for prevention of hyperstimulation. Group B will include patients at risk of ovarian hyperstimulation syndrome (OHSS) not receiving Cabergoline. While group C will serve as a control group and will include age & BMI matched patients not at risk of OHSS, and not receiving cabergoline.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥18 - ≤40 years
- •Normal serum prolactin level.
- •Tubal factor of infertility.
- •Unexplained infertility.
- •BMI ≥ 30 kg/m
- •Estradiol (E2)>3,500 pg/ml on day of ovulation trigger.
- •Patients who underwent coasting for OHSS prevention.
- •More than 20 follicles ≥11 mm on the day of final oocyte maturation.
- •Exclusion criteria:
- •Contraindication of pregnancy e.g.: Somatic and mental diseases, which are contraindications for carrying of a pregnancy and childbirth, inborn malformations or acquired deformations of uterus cavity which make embryo implantation or carrying of a pregnancy impossible ,ovarian tumors.
- •Severe Male factor infertility.
- •Hyperprolactinemic patients.
- •Frozen embryo transfer cycles
- •Uterine Anomalies.
- •Uterine synechia.
- •History of Genital Tuberculosis.
- •Repeated implantation failure in ICSI.
- •On medication that is known to alter prolactin levels e.g antipsychotics, Atypical agents and risperidone
- •Thyroid dysfunction.
- •Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and hypothyroidism
Exclusion Criteria
- Not provided
Arms & Interventions
Group A
Group A will include patients at risk of OHSS receiving Cabergoline 0.5mg daily for 8 days (Dostinex®, Pfizer Australia Pty Ltd ) from the day of oocyte pick up for prevention of hyperstimulation
Intervention: Cabergoline (Drug)
Outcomes
Primary Outcomes
Pregnancy rate (chemical , clinical).
Time Frame: 2 weeks after embryo transfer
beta human chorionic gonadotrophin (βHCG) \>10 IU on day 12 after embryo transfer
Secondary Outcomes
- Vascularization index (VI)(5 days)
- Miscarriage rate(3 weeks after positive βHCG)
- OHSS rate(4 weeks)
- Flow index (FI)(5 days)
- vascularization flow index (VFI)(5 days)
- pulsatility index (PI)(5 days)
- the resistance index (RI)(5 days)
- the peak systolic velocity (Vp).(5 days)
- the end-diastolic velocity (Vd).(5 days)
Investigators
Ahmed M.Kamel
Lecturer of Obstetric & Gynecology
Kasr El Aini Hospital