Cabergoline and Coasting to Prevent OHSS

OHSS Clinical Trial

— OHSS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984320
• Other study ID #: 92013
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: August 11, 2017
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age <or= 35, BMI <or= 30

2. Long protocol GnRH agonist cycles

3. Estradiol level on day of HCG >or= 3500 pg/ml

4. Retrieving more than 15 oocytes

Exclusion Criteria:

1. Male factor

2. Uterine factor

Related Conditions & MeSH terms

• OHSS
• Ovarian Hyperstimulation Syndrome

Intervention

Procedure:
• ICSI
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.

Locations

Country	Name	City	State
Egypt	IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Esinler I, Bozdag G, Karakocsokmensuer L. Preventing ovarian hyperstimulation syndrome: cabergoline versus coasting. Arch Gynecol Obstet. 2013 Nov;288(5):1159-63. doi: 10.1007/s00404-013-2875-z. Epub 2013 May 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Metaphase II (MII) oocytes	Number of MII oocytes collected on the day of oocyte collection	1 day
Other	Fertilization rate	Number of embryos that show signs of fertilization in each patient	2 days
Other	Number of embryos	Number of embryos assessed for embryo transfer in each patient	3 to 5 days
Other	Implantation rate	the ratio of the number of gestational sacs to the number of embryos transferred	5 weeks
Other	Chemical pregnancy rate	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	14 days
Other	Clinical pregnancy rate	patients who show an intra-uterine gestational sac with positive fetal pulsations on ultrasound 14 days after their pregnancy test	28 days
Other	Early miscarriage rate	pregnancy loss in the first 12 weeks of gestation	12 weeks
Other	Ongoing pregnancy rate	pregnancies going beyond 12 weeks of gestation	12 weeks
Other	Live birth rate	live births occuring	40 weeks
Primary	Rate and degree of OHSS (composite outcome)	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)	14 days
Secondary	Number of oocytes	Number of oocytes collected on the day of oocyte collection	1 day