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NCT Number: NCT06769789

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

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

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Key information

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug free invitro activation Ovary

Other

Drug free invitro activation Ovary

Primary outcomes

  1. The number of oocytes obtained at oocyte pick-up (OPU)

    Time frame: Within 3 weeks after ovarian stimulation

  2. Number of embryos

    Time frame: Within 3 weeks after ovarian stimulation

  3. Quality of embryos at the end of IVF treatment

    Time frame: 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 outcomes

  1. Implantation rate

    Time frame: 4-8 weeks after transfer

  2. Clinical pregnancy rate

    Time frame: one month after transfer

  3. Miscarriage rate

    Time frame: 20 weeks after transfer

Study contacts

Contact information is provided by the study sponsor or research team.

Malihe Mahmoudinia

CONTACT

[email protected]

_+98513338801

Sponsors and collaborators

Lead sponsor

Malihe Mahmoudinia

Other

Registry information

Official study title

Evaluation of Pregnancy Outcome in Poor Responder Patients in IVF Cycle with Usage of Drug-free In-vitro Activation of Follicles Ovary

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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