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

Malihe Mahmoudinia

Status: Not yet enrolling

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

Treatments: Other: Drug free invitro activation Ovary

Study type: Interventional

Funder types: Other

Identifiers

NCT06769789

IR.MUMS.IRH.REC.1403.127

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 estimated patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Experimental: Drug -free invitro activation of ovary in women

Experimental group

Treatment:

Other: Drug free invitro activation Ovary