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IRCT20150105020558N6 IRCT 2023-02-28 Tehran University of Medical Sciences Investigating the effect of increasing the amount of prescribed progesterone on the pregnancy success rate Investigating the effect of daily intramuscular injection of 50 mg progesterone and 800 mg progesterone suppository on the pregnancy success rate in women with low progesterone levels 2023-04-09 anticipated 218 Complete https://irct.ir/trial/68827 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation, there are 109 small envelopes containing letter A and 109 small envelopes in the same shape containing letter B in a bag, and for each patient, one envelope is selected randomly. 3 Female infertility. Intervention 1: Intervention group: From the day of embryo transfer, 50 mg ampoule progesterone (intramuscular injection) is prescribed once a day in addition to 400 mg progesterone suppositories every 12 hours. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drugs are continued until 12 weeks after transfer, otherwise, the drugs are stopped. Intervention 2: Control group: From the day of embryo transfer, 400 mg progesterone suppositories every 12 hours are prescribed. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drug is continued until 12 weeks after transfer, otherwise, the drugs are stopped. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants. When: After the manuscript is published. To whom: No limitations. Conditions: Those who are allowed to request to receive non-identifiable personal data or other documents must have a written proposal (including the type of statistical analysis) and the ethics number. any additional analysis must perform under the corresponding author's supervision. Where to obtain: Communicate with the corresponding author via email: maeb214@yahoo.com How to obtain: Any request must be sent through e-mail and accompanied by a proposal with an ethics code under the supervision of Dr. Ebrahimi. Comments:
public Mahbod Ebrahimi
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0000 maeb214@yahoo.com Tehran University of Medical Sciences scientific Mahbod Ebrahimi
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0000 maeb214@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women with a three-layered endometrial pattern with sufficient thickness (7 mm) after receiving estrogen Progesterone level less than 9.2 ng/ml on the day of transfer With at least two three-day frozen embryos of good quality (AA, AB, BB) 18 years 38 years Female The presence of underlying diseases such as malignancy, advanced heart failure, cirrhosis, progressive chronic neurological diseases, and uterine disorders such as fibroids, polyps, or hydrosalpinx. N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: From the day of embryo transfer, 50 mg ampoule progesterone (intramuscular injection) is prescribed once a day in addition to 400 mg progesterone suppositories every 12 hours. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drugs are continued until 12 weeks after transfer, otherwise, the drugs are stopped. Control group: From the day of embryo transfer, 400 mg progesterone suppositories every 12 hours are prescribed. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drug is continued until 12 weeks after transfer, otherwise, the drugs are stopped. Live birth. Timepoint: Once, after pregnancy termination. Method of measurement: The number of deliveries that resulted in a live-born neonate. Tehran University of Medical Sciences Approved 2023-02-12 Ethical Committee of Tehran University of Medical Sciences Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd. Tehran Tehran Iran (Islamic Republic of)