Clinical trial

Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial

Name

Infertility-Uterine flushing

Description

One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.

Trial arms

Trial start

2018-11-01

Estimated PCD

2022-12-01

Trial end

2023-01-01

Status

Completed

Phase

Early phase I

Treatment

Intrauterine flushing of follicular fluid with granulosa cells

All patients in case and control groups will receive agonist and antagonist protocol. Ovarian stimulation will be carried out when pituitary desensitization is achieved and is continued until the day of hCG administration. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Endometrial flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. The control group included 70 women who 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.

Arms:

Intrauterine flushing follicular fluid

Size

140

Primary endpoint

Implantation rates

Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])

Eligibility criteria

Inclusion Criteria: 1. Normal Hormonal profile (FSH, LH, AMH) and normal AFC 2. Normal ovarian reserve 3. Age 20-38 years 4. Regular menstrual cycle 5. IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol 6. Existence of at least 2 oocytes in dominant follicular fluids Exclusion Criteria: 1. Presence of Endometriosis and Endometrioma 2. Hydrosalpinx 3. OHSS (Ovarian Hyper Stimulating Syndrome) 4. Tubal factor infertility 5. Male factor infertility with azoospermia 6. Low/Poor Response 7. Myoma with a compression effect or submocusa myometrium 8. Intra mural or subserouse Myoma \> 5cm 9. Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection. 10. Endometrial tuberculosis 11. The follicular fluid which contains any oocyte or contaminated with blood will be discarded

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}

Updated at

2023-03-14

1 organization

1 product

3 indications

Organization

Royan Institute

Product

Intrauterine flushing of follicular fluid with granulosa cells

Indication

Follicular Fluid

Indication

Granulosa Cell

Indication

Embryo Implantation