Progesterone Clinical Trial
Official title:
Comparison of the Effect of Subcutaneous Progesterone and Vaginal Progesterone for Luteal Phase Support in Intrauterine Insemination
Verified date | September 2022 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The invesigators aimed to seperate the patients,which is going to be applied IUI, to two different groups as prospective randomized controlled ;assess the efficacy of the two different way pressurised progesterone by appling intravaginal progesterone to the first group; subcutaneous to the second group.
Status | Completed |
Enrollment | 146 |
Est. completion date | September 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Absence of follicles larger than 10 mm on basal ultrasound - Endometrial thickness less than 5 mm - Patients with FSH<10 IU/ml, E2<60-80 pg/ml in the blood hormone test performed on the third day of the cycle and patients with antral follicle count above 7 on ultrasound - Total motile sperm count greater than 10 million/ml - 18-40 years old female, 18-50 years old male - Anovulation, patients diagnosed with unexplained mild male factor infertility - Female partners, who's BMI<25 kg/m² - Being voluntarily Exclusion Criteria: - Other infertility reasons - The patients who doesn't meet the criterias - Refusing to attend to the research |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Erdem A, Erdem M, Atmaca S, Guler I. Impact of luteal phase support on pregnancy rates in intrauterine insemination cycles: a prospective randomized study. Fertil Steril. 2009 Jun;91(6):2508-13. doi: 10.1016/j.fertnstert.2008.04.029. Epub 2008 Aug 9. — View Citation
Green KA, Zolton JR, Schermerhorn SM, Lewis TD, Healy MW, Terry N, DeCherney AH, Hill MJ. Progesterone luteal support after ovulation induction and intrauterine insemination: an updated systematic review and meta-analysis. Fertil Steril. 2017 Apr;107(4):924-933.e5. doi: 10.1016/j.fertnstert.2017.01.011. Epub 2017 Feb 24. Review. — View Citation
Keskin M, Aytaç R. Does Luteal Phase Support Effect Pregnancy Rates in Intrauterine Insemination Cycles? A Prospective Randomised Controlled Study in a Tertiary Center. Obstet Gynecol Int. 2020 Aug 5;2020:6234070. doi: 10.1155/2020/6234070. eCollection 2020. — View Citation
Khosravi D, Taheripanah R, Taheripanah A, Tarighat Monfared V, Hosseini-Zijoud SM. Comparison of oral dydrogesterone with vaginal progesteronefor luteal support in IUI cycles: a randomized clinical trial. Iran J Reprod Med. 2015 Jul;13(7):433-8. — View Citation
Maher MA. Luteal phase support may improve pregnancy outcomes during intrauterine insemination cycles. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):57-62. doi: 10.1016/j.ejogrb.2011.03.022. Epub 2011 Apr 21. — View Citation
Oktem M, Altinkaya SO, Yilmaz SA, Bozkurt N, Erdem M, Erdem A, Gumuslu S. Effect of luteal phase support after ovulation induction and intrauterine insemination. Gynecol Endocrinol. 2014;30(12):909-12. doi: 10.3109/09513590.2014.947567. Epub 2014 Aug 7. — View Citation
Ozcan P, Takmaz T. Identification of predictive factors for the probability of pregnancy following ovulation stimulation-intra-uterine insemination cycles in terms of female and male. J Obstet Gynaecol Res. 2021 Mar;47(3):893-899. doi: 10.1111/jog.14594. Epub 2021 Jan 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate | after iui betahcg levels blood sampling | day 15 | |
Secondary | Ongoing pregnancy rate | Ongoing pregnancy rates 3 months after iui | Months 3 |
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