drugset / Trial / NCT03263299

Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol

NCT03263299

Phase 4 Unknown 120 enrolled Cairo University
RandomizedParallel-groupTriple-blindTreatment

Summary

Ovarian stimulation will be done using the Microdose flare-up regimen. The patient will receive diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation will be initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day. Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany) will be injected when at least 2 follicles 18 mm were observed on ultrasonography. Oocytes willbe retrieved 36 hours after hCG injection using a 17-gauge aspiration needle under transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure that there is no internal bleeding. After fertilization was confirmed when two polar bodies and two pronuclear were observed 18-20 hours after insemination, one to three grade A embryos were transferred at day 3 fertilization. The luteal phase support will be initiated from the day of oocyte retrieval for all patients with (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the day of serum pregnancy test was done.

Timeline

Start
2017-08
Primary completion
2018-08
Completion
2018-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 80 mg
Comparator Cabergoline Small molecule 1 mg
Comparator Leuprolide Other / unclassified 40 ug Subcutaneous
Comparator Merional Unknown 300 iu Intramuscular

Indications

No indication recorded.