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IRCT201107266420N4 IRCT 2011-09-18 Yazd reaserch and clinical center for infertility Comparison of two protocols for transfer of the frozen embryos Evaluation of human chorionic gonadotropin (HCG) addition during secretary phase in frozen-thawed embryo transfer cycles 2009-01-01 anticipated 150 Complete https://irct.ir/trial/6862 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization by table of random numbers. 2 infertility. Intervention 1: Intervention: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age. HCG 5000 IU is injected in the first day of progesterone injection and in the day of embryo transfer. Intervention 2: Control: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3850306/pdf/Int-J-Fertil-Steril-6-175.pdf Abstract Background: Human chorionic gonadotropin (HCG), one of the initial embryonic signals, is probably a major regulator of the embryo-endometrial relationship. This study aims to assess the advantage of HCG supplementation during the secretory phase of hormonally prepared cycles for the transfer of cryopreserved-thawed embryos. Materials and Methods: This study was a randomized clinical trial. Infertile women who were candidates for frozen-thawed embryo transfers entered the study and were divided into two groups, HCG and control. The endometrial preparation method was similar in both groups: all women received estradiol valerate (6 mg) po per day from the second day of the menstrual cycle and progesterone in oil (100 mg) intramuscular (I.M.) when the endometrial thickness reached 8 mm. Estradiol and progesterone were continued until the tenth week of gestation. In the HCG group, patients received an HCG 5000 IU injection on the first day of progesterone administration and the day of embryo transfer. Results: In this study, 130 couples participated: 65 in the HCG group and 65 in the control group. There was no statistically significant difference between groups regarding basic characteristics. Implantation rate, chemical pregnancy, clinical pregnancy, ongoing pregnancy, and abortion rates were similar in both groups. Conclusion: Although HCG has some advantages in assisted reproductive technology (ART) cycles, our study did not show any benefit of HCG supplementation during the secretory phase of frozen cycles (Registration Number: IRCT201107266420N4). Keywords: ART, Implantation, Frozen Embryo, HCG Yes - There is a plan to make this available What will be shared: All participant data sets are to be shared When: 2 months after the result publication To whom: A journal in which the results are published Conditions: Submission of an official application via the agent that is legally in charge Where to obtain: Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085 How to obtain: Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data. Comments:
public Dr Maryam Eftekhar
Bouali Avenue, Safayeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 eftekhar@ssu.ac.ir Yazd research center for infertility scientific Dr Maryam Eftekhar
Bouali Avenue, Safayeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 eftekhar@ssu.ac.ir Yazd reserarch and clinical center for infertility Iran (Islamic Republic of) Inclusion criteria: History of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) fail; cryopreservation of excess embryos 18 years 38 years Female age >38 years; BMI>30; history of endocrine disorder; severe endometriosis. N99 Postprocedural disorders of genitourinary system, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age. HCG 5000 IU is injected in the first day of progesterone injection and in the day of embryo transfer. Control: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age. Chemical pregnancy. Timepoint: 2 weeks. Method of measurement: serum BHCG. Clinical sonography. Timepoint: 2 weeks. Method of measurement: sonography. Yazd reaserch and clinical center for infertility Approved 2011-06-20 Yazd reserch and clinical center for infertility Booali street Yazd Yazd Iran (Islamic Republic of)