Antagonist Protocol in Poor Responders

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Female Infertility Due to Diminished Ovarian Reserve

Treatments: Drug: Growth Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT02195947

72014

Details and patient eligibility

About

The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

Full description

Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Enrollment: 141 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• females fulfilling the criteria of the ESHRE consensus 2011:
• at least two of the following three features must be present:
• dvanced maternal age (≥40 years) or any other risk factor for POR
• previous POR (≤3 oocytes with a conventional stimulation protocol)
• an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

Exclusion criteria

• women who suffer from any other cause of infertility other than poor ovarian reserve
• refusal of the patient to consent for using her data in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Antagonist and Growth hormone

Experimental group

Description:

HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

Treatment:

Drug: Growth Hormone

Antagonist

No Intervention group

Description:

HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC