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atural frozen – thawed embryo transfer cycles

Phase 2
Conditions
female infertility.
female infertility
Registration Number
IRCT201108044339N6
Lead Sponsor
Yazd University of Medical Sciences
Brief Summary

Abstract Background: The transfer of cryopreserved embryos can be timed with ovulation in a natural cycle or after artificially preparing the endometrium with exogenous hormones. Progesterone is essential for the secretory transformation of the endometrium that permits implantation as well as maintenance of early pregnancy. The purpose of this study is to assess the effect of luteal phase supplementation on pregnancy rates in natural frozen-thawed cycles. Materials and Methods: The study was designed as a prospective randomized clinical trial of 102 women who underwent embryo transfers in natural cycles. The women in the interventional group (n=51) received intra muscular (IM) progesterone 50 mg twice a day starting from 36 hours after hCG administration. The control group (n=51) did not receive any progesterone support. Results: There were no significant differences in demographic characteristics between the groups and no statistically significant differences were observed between study and control groups in clinical pregnancy rate (33.3% vs. 27.5%, p=0.66). There were no differences in implantation rate or spontaneous abortion rate. Conclusion: Our results suggest that luteal phase support does not affect clinical pregnancy rates in natural frozen-thawed embryo transfer cycles (Registration Number: IRCT201108044339N6).

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
109
Inclusion Criteria

cryop reserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
maternal age of 20-40 years (on the day of embryo freezing)
regular menstrual cycle of 25-35 days
body mass index of 20-27 kg/m2

Exclusion Criteria

the use of testicular sperm for ICSI (ejaculated sperm only)
basal follicle stimulating hormone
stage III-IV endometriosis
polycystic ovarian syndrome (PCOS)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: BHCG TEST.
Secondary Outcome Measures
NameTimeMethod
Clinical pregnancy. Timepoint: 4-5 weeks after embryo transfer. Method of measurement: Obestetrics sonography.;Implantation rates. Timepoint: Five weeks after embryo transfer. Method of measurement: The number of pregnancy sacs divided by the number of transferred embryos multiplied by 100.;Clinical abortion. Timepoint: before20 weeks of gestation. Method of measurement: as clinically.
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