Gonadotropin-releasing hormone (GnRH) antagonist vs. gonadotropin-releasing hormone agonist protocol for in vitro fertilization in non-obese patients with Polycystic Ovary Syndrome (PCOS). A prospective randomized study.

A prospective randomized study comparing clinical and embryological outcomes in controlled ovarian hyperstimulation protocols with GnRH antagonist and GnRH agonist for in vitro fertilization in PCOS non-obese patients.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000636459

Enrollment

Registered

2007-12-13

Start date

2004-02-02

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many clinical trials demonstrate that overall outcomes are comparable in GnRH agonists and antagonists protocols. However, recent data suggest that the duration of stimulation as well as the incidence of severe OHSS are significantly reduced in COH protocols with GnRH antagonist. There are only few studies comparing clinical outcome of GnRH agonist and antagonist protocols in PCOS patients. Nevertheless, none of those studies include a detailed embryological description. Because obesity was reported to be associated with relative gonadotropin resistance as well as lower number of collected oocytes we excluded obese patients. Mentioned studies did not consider high BMI as an exclusion criteria. In the current study, we decided to verify if women with PCOS can also benefit from GnRH antagonist protocol. Additionally, since the relative importance and the role of monitoring of LH in follicular development is still disputable we investigate correlation between LH levels and the treatment outcome.

Interventions

Controlled ovarian hyperstimulation with GnRH antagonists (Cetrotide 0,25 mg/day; intramuscular; starting when the two follices reach the diameter of 14mm untill the criteria for human chorionic gonadotropin administartion) and agonists (Triptorelin 3,75 mg; intramuscular; once, on the 20-22 day of the preceding cycle), intracytoplasmic sperm injection

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 40 Years

Healthy volunteers

Yes

Inclusion criteria

1. meeting of 2003 Rotterdam PCOS criteria; 2. age=40 years; 3. body mass index <27 kg/m2; 4. FSH < 12 mIU/ml on the 3rd day of the cycle; 5. negative screening for hepatitis B and C virus infection and human immunodeficiency virus (HIV) infection.

Exclusion criteria

>2 miscarriages, >3 unsuccessful IVF/ICSI cycles, anatomical abnormalities of the uterus on laparoscopy or hysteroscopy and existence of ovarian cysts.

Outcome results