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IRCT20080831001141N29 IRCT 2020-12-19 ROYAN Institute Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells Evaluation of implantation rate and clinical pregnancy after intrauterine flushing of infertile patients with follicular fluid plus granulosa cells 2018-11-01 anticipated 140 Complete https://irct.ir/trial/53043 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Consecutive sampling until the required sample size is reached. Women by Balanced Block Randomization method are randomly divided into 2 equal groups of 70 people (intervention group and control group). Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 4. Envelopes are prepared for 140 people and inside each envelope is written the group in which the patient should be placed. The envelopes are prepared in a way that the writing inside is not clear. A nurse before the patient enters the operating room, removes the envelope and sends the patients in one of the two groups, Blinding description: In this study, a doctor performs intrauterine flushing of follicular fluid with granulosa cells in the intervention group. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Therefore, in this study, it is not possible to blind the doctor. In order to blind the patients participating in this study, all conditions will be the same between the two groups (participating patients blindness). All patients in case and control groups will receive GnRH agonist protocol. Ovarian stimulation will be carried out when pituitary desensitization is achieved and is continued until the day of hCG administration. The control group would not have FF endometrial flushing. In both groups, embryo transfer will be carried out 2-3 days later. Luteal phase support will be started the day after ovum pick up by the vaginal administration of progesterone daily for 16 days and will continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-hCG level and later was confirmed by Transvaginal sonography. The researcher also reviews the results based on the received code (researcher blindness). 3 Infertile women with male factor. Intervention 1: Intervention group: Women will undergo intrauterine flushing with follicular fluid plus granulosa cells. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Follicular fluid flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. Intervention 2: Control group: Women will not undergo intrauterine flushing with follicular fluid plus granulosa cells. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public Conditions: Scientific use by citing the source Where to obtain: Dr. Maryam Hafezi How to obtain: Request via e-mail Comments:
public Maryam Hafezi
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2727 maryamhafezi90@yahoo.com ROYAN Institute scientific Maryam Hafezi
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2727 maryamhafezi90@yahoo.com ROYAN Institute Iran (Islamic Republic of) Normal Hormonal profile (FSH, LH, AMH) and normal AFC Normal ovarian reserve Age 20-38 years Regular menstrual cycle IVF / ICSI or IVF or ICSI cycles with Agonist Protocol Existence of at least 2 oocytes in dominant follicular fluids 20 years 38 years Female Presence of Endometriosis and Endometrioma Hydrosalpinx OHSS (Ovarian Hyper Stimulating Syndrome) Tubal factor infertility Age <38 years old Male factor infertility with azoospermia Low/Poor Response Myoma with a compression effect or submocusa myometrium Intra mural or subserouse Myoma > 5cm Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection Endometrial tuberculosis Patients with any special drug intake The follicular fluid which contains any oocyte or contaminated with blood will be discarded N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Intervention group: Women will undergo intrauterine flushing with follicular fluid plus granulosa cells. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Follicular fluid flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. Control group: Women will not undergo intrauterine flushing with follicular fluid plus granulosa cells. Evaluation of implantation rate. Timepoint: Only once, day 35-42 post ovum pick-up. Method of measurement: Based on the number of gestational sacs observed, divided by the number of embryos transferred. Clinical pregnancy rate. Timepoint: Only once; 6 weeks after embryo transfer. Method of measurement: Vaginal ultrasound. NCT04077970 مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov) ROYAN Institute Approved 2017-08-15 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway Tehran Tehran Iran (Islamic Republic of)