Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary

Not Applicable

Not yet recruiting

• Conditions: Infertility (IVF Patients); Infertile Females or Females with Ovarian Insufficiency

• Registration Number: NCT06769789
• Lead Sponsor: Malihe Mahmoudinia

Brief Summary

This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women

Detailed Description

First, patients who are poor responders based on Poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an IVF cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. The patient has a history of poor response in previous IVF cycles. After obtaining the patient's consent, the patient undergoes laparoscopy. The laparoscopy procedure will be performed at Milad Infertility Center, which is equipped with a laparoscopy operating room and a laboratory nearby. The procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. After general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. Two minor trocars will be placed, which will be held in place by an ovarian grasper. With scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. They are immediately transferred to the adjacent laboratory. A 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. The tissue is then divided into 1 x 1 x 1 mm pieces. The removal site will be sutured in case of bleeding. The preparation of the ovary into small pieces will be performed by a single physician for all patients. The prepared pieces are immediately transferred to the operating room. Then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. The patient is then followed up and immediately treated with FSH (Sinagene Company, Tehran, Iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. When a 12 mm follicle is observed, 0.25 mg of Sterotide (Merck Serono, Mississauga, Canada) is started. When the size of 1 or 2 follicles reaches 16, 10,000 units of HCG (Puyish Daru Company, Tehran, Iran) and two ampoules of Deca (Decapeptyl 0.2 mg, Ferring, Germany) are given together for triggering. Ovulation is performed 36 hours later under transvaginal ultrasound guidance.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study Start: 2025-01-10
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-01-10
• Study Completion: 2027-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Women under 35 years of age who have one of the following characteristics:

Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)

Or ovarian reserve test AMH less than 1.1

Exclusion Criteria

• Unwillingness to continue working with the researcher during the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The number of oocytes obtained at oocyte pick-up (OPU)	Within 3 weeks after ovarian stimulation
Number of embryos	Within 3 weeks after ovarian stimulation
Quality of embryos at the end of IVF treatment	Within 3 weeks after ovarian stimulation	A grade embryo was defined to have four blastomeres on the second day and seven or eight blastomeres on the third day with equal size and \<20% fragmentation (high quality). Blastocyst embryos were assessed according to Gardner's criteria.

Secondary Outcome Measures

Name	Time	Method
Implantation rate	4-8 weeks after transfer
Clinical pregnancy rate	one month after transfer
Miscarriage rate	20 weeks after transfer