Poor Responders Infertile Patients -A Great Clinical Challenge

NCT ID: NCT03402620

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2018-06-04

Brief Summary

infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules

Detailed Description

Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by TVUS scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF) reaches >12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will be given only if we have at least 3 mature follicles >14 mm and the leading one >17 mm; then, ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI, and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the transferring consultants have more than 5 years experience in IVF unit. . All patients will receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom) 800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level was assessed on day 14 after ET and considered positive if >5 mIU/ml. The TVUS was performed 28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.

Conditions

Invitro Fertilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

four ampoules group

gonadotropin starting dose is 4 ampoules daily

Group Type: ACTIVE_COMPARATOR

Gonadotropins

Intervention Type: DRUG

Human menopausal gonadotropin 75 IU ampoules start at cycle day 2

six ampoules group

gonadotropin starting dose is 6 ampoules daily

Group Type: ACTIVE_COMPARATOR

Gonadotropins

Intervention Type: DRUG

Human menopausal gonadotropin 75 IU ampoules start at cycle day 2

Interventions

Gonadotropins

Human menopausal gonadotropin 75 IU ampoules start at cycle day 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:

1. Age >40 years or other cause of poor function.

2. AFC<2-5 in both ovaries or AMH < 0.5-1.1 ng/dl 2)

3. History of poor response with conventional stimulation protocol

Exclusion Criteria

1. Uterine factor.

2. Severe male factor.

3. Endometriosis.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

20

Identifier Type: -

Identifier Source: org_study_id