An additional rescue dose of GnRH antagonist administered the day before hCG trigger is effective to prevent ovarian hyperstimulation syndrome (OHSS) in IVF/ICSI antagonist cycles at risk for OHSS without affecting the reproductive outcomes

• Register: ISRCTN
• Last refreshed on: 20 November 2017
• Main ID: ISRCTN02750360
• Date of registration: 13/08/2014
• Prospective Registration: No
• Primary sponsor: IAKENTRO (Greece)
• Public title: An additional rescue dose of GnRH antagonist administered the day before hCG trigger is effective to prevent ovarian hyperstimulation syndrome (OHSS) in IVF/ICSI antagonist cycles at risk for OHSS without affecting the reproductive outcomes
• Scientific title: An additional rescue dose of GnRH antagonist administered the day before hCG trigger is effective to prevent OHSS in IVF/ICSI antagonist cycles at risk for OHSS without affecting the reproductive outcomes: a prospective randomized controlled trial
• Date of first enrolment: 01/11/2009
• Target sample size: 194
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN02750360
• Study type: Interventional
• Study design: Prospective randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: Yannis Prapas

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients age 18-40 years, at high risk for OHSS who underwent ovarian stimulation for in vitro fertilization (IVF) using the 6th day fixed GnRH antagonist protocol. Patients were considered at actual risk of developing moderate to severe OHSS when they had a high or rapidly rising serum estradiol (=3500 pg/ml before oocyte maturation and projected to be >4500 pg/ml the day of hCG administration) and 18 or more follicles =11 mm but without any mature follicle >16 mm appearing at that time.
2. With polycystic ovaries (The Rotterdam ESHRE/ASRM-sponsored PCOS consensus Workshop Group, 2004)
3. At high risk for OHSS
4. Not willing to cancel their IVF cycle
Exclusion criteria: Polycystic ovarian syndrome (PCOS) patients

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian hyperstimulation syndrome (OHSS), ovarian stimulation, GnRH antagonist, IVF
Pregnancy and Childbirth

Intervention(s)

Patients were randomised to:
1. Intervention group A (down-regulate FSH daily dose to 100 iu, up until hCG trigger and receive double GnRH antagonist dose the day before hCG trigger)
2. Control group B (down-regulate FSH daily dose to 100 iu, up to the hCG trigger)

Patients were considered at actual risk of developing moderate to severe OHSS when they had a high or rapidly rising serum estradiol (=3500 pg/ml before oocyte maturation and projected to be >4500 pg/ml the day of hCG administration) and 18 or more follicles =11 mm but without any mature follicle >16 mm appearing at that time. A standard fixed 6th day antagonist protocol (Orgalutran 0.25 mg, Organon) with 225 IU/day recombinant FSH (rFSH, Puregon Organon) starting on day 2 of the cycle was used for the ovarian stimulation. In the 5th and 7th day of stimulation the rFSH daily dose, if needed, was adjusted according to ovarian response, accounting ultrasound control of growing follicles and oestradiol levels (blood sample). The criteria for the allocation of patients to the study groups were met from the 7th day of stimulation and onwards. Final oocyte maturation was achieved by administration of 10.000 IU of hCG (Pregnyl, NV Organon, the Netherlands) as soon as three or more follicles of =17mm were present on ultrasound control. Transvaginal oocyte aspiration was performed 36 hours after hCG administration by ultrasound-guided follicle puncture. All women were examined clinically and by ultrasound three and five days after oocyte retrieval or earlier if any discomfort appeared, for signs of moderate or severe OHSS using grading criteria (Golan et al., 1989; Grossman et al., 2010). If these symptoms of OHSS were present, the embryo transfer was cancelled, all embryos were cryo-preserved at the stage of blastocyst. Patients in both groups, without signs of OHSS had at least one embryo transferred on day 5 after OPU (blastocyst stage). A pregnancy test was performed 15 days after embryo transfer. The concu

Primary Outcome(s)

1. Early and late OHSS rates
2. Clinical pregnancy rate

Secondary Outcome(s)

1. Oestradiol (E2)
2. Luteizing hormone (LH)
3. Progesterone (PR) levels

Secondary ID(s)

N/A

Source(s) of Monetary Support

IAKENTRO fertility centre (Greece)