Poor Responders Infertile Patients -A Great Clinical Challenge

Invitro Fertilization Clinical Trial

Official title:

Starting Dose of Gonadotropin for Poor Responders in IVF Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402620
• Other study ID #: 20
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: June 4, 2018

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invitro Fertilization

Intervention

Drug:
• Gonadotropins
Human menopausal gonadotropin 75 IU ampoules start at cycle day 2

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of retrieved oocytes	The number of oocyte retrived at ovum pickup	34 hours after HCG triggering