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The effect of decapeptile on treatment of infertile women in ICSI(Intracytoplasmic Sperm Injection) cycles

Phase 3
Conditions
Infertility.
Female infertility, unspecified
Registration Number
IRCT2012111111430N1
Lead Sponsor
Reaserch center of Avicenna
Brief Summary

GnRH agonist administration in the luteal phase has been suggested to beneficially affect the outcome of intracytoplasmic sperm injection (ICSI) and embryo transfer (ET) cycles. This blind randomized controlled study evaluates the effect of GnRH (Gonadotropine Releasing Hormone) agonist administration on ICSI outcome in GnRH antagonist ovarian stimulation protocol in women with 2 or more previous IVF/ICSI-ET failures.<br /> <br /> Methods<br /> <br /> One hundred IVF failure women who underwent ICSI cycles and stimulated with GnRH antagonist ovarian stimulation protocol, were included in the study. Women were randomly assigned to intervention (received a single dose injection of GnRH agonist (0.1 mg of Decapeptil) subcutaneously 6 days after oocyte retrieval) and control (did not receive GnRH agonist) groups. Implantation and clinical pregnancy rates were the primary outcome measures.<br /> <br /> Results<br /> <br /> Although the age of women, the number of embryos transferred in the current cycle and the quality of the transferred embryos were similar in the two groups, there was a significantly higher rate of implantation (Mann Whitney test, p = 0.041) and pregnancy (32.6% vs. 12.5%, p = 0.030, OR = 3.3, 95%CI, 1.08 to 10.4) in the intervention group.<br /> <br /> Conclusion<br /> <br /> Our results suggested that, in addition to routine luteal phase support using progesterone, administration of 0.1 mg of Decapeptil 6 days after oocyte retrieval in women with previous history of 2 or more IVF/ICSI failures led to a significant improvement in implantation and pregnancy rates after ICSI following ovarian stimulation with GnRH antagonist protocol.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
100
Inclusion Criteria

Inclusion: couples with two or more IVF Failure with good quality embryo transfer; women with antagonist cycle; women with at least one embryo for transfer; women under IVF wiht ones gamet and women under 42 years.
Exclusion criteria: cycles with preimplantation genetic diagnosis; women with anatomical uterine disorders or hydrosalpinx and women with thyroid disorders.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pregnancy. Timepoint: Ten days, 3 weeks, 3 months and 5 months after. Method of measurement: HCG, sonography, follow up.
Secondary Outcome Measures
NameTimeMethod
Abortion. Timepoint: every 3 months. Method of measurement: sonography-follow up.;Twin pregnancy. Timepoint: Vaginal ultrasonography in 6-8 weeks. Method of measurement: Number of gestational sacs.
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