Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase

NCT ID: NCT02333253

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

Brief Summary

40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC.

Detailed Description

40 patients attending IVF center during 2013 &2014 were fulfilling criteria of poor response and they failed to go through OPU as they gave <3 mature follicles on a dose of 300U GN or more. All patients were revised for history, examinations and investigations, including age, type and duration of infertility, day 3 FSH, Day 3 E2, AMH, AFC All patients were 35 years old ore more We exclude patient >44ys ,AMH <0.3ng/ml,FSH >13, also patients of DM, endometriosis, general disease were excluded, any local uterine anomalies were excluded.

All patients received OCP for one cycle Then all had taken estradiol tablet 2 mg for one week prior to menses of the test cycle from Day 21 to day 28 Then we divide them into 2 groups US were done to exclude any cyst or follicle >10mm First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach >12 mm, HCG was given only if we have at least 3 mature follicles >14 mm and the leading one >17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if > 5miu/ML 28 day after ET, TVS was done to confirm ongoing pregnancy by visualization of IU sac.

Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF >12mm, till day of HCG, HCG,OPU, ET were done by same method and under same criteria, luteal support and follow were the same.

Conditions

Other Complications Associated With Artificial Fertilization

Study Design

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

Study Groups

Delayed start protocol

First group received 300 U r FSH +150 U urinary GN from day 2 till day of HCG ,dose adjusted according to the response then 0.25 cetrotide S.c was added on when leading follicle reach \>12 mm, HCG was given only if we have at least 3 mature follicles \>14 mm and the leading one \>17mm then OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if \> 5miu/ML

Group Type: ACTIVE_COMPARATOR

cetrotide

Intervention Type: DRUG

0.25 cetrotide S.c was added on when leading follicle reach \>12 mm

conventional antagonist protocol

Second group were received cetrotide 0.25 mg s.c alone from day 2 to day 8then we initiate GN therapy by same initial GN dose (300FSH+150U urinary GN).same adjustment of dose were done and antagonist restarted when DF \>12mm, till day of HCG, OPU done after 36 hrs of HCG, oocytes were denuded and fertilized by ICSI to avoid low fertilization rate by conventional IVF,embryo transfer were done on day 3 when we have at least one embryo GI other wise cancelled ET, then cyclogest 800mg were given intravaginal for 14 days then quantitative BHCG done and considered positive if \> 5miu/ML

Group Type: ACTIVE_COMPARATOR

cetrotide

Intervention Type: DRUG

0.25 cetrotide S.c was added on when leading follicle reach \>12 mm

Interventions

cetrotide

0.25 cetrotide S.c was added on when leading follicle reach \>12 mm

Intervention Type: DRUG

Other Intervention Names

cetrorelix acetate

Eligibility Criteria

Inclusion Criteria

1 Poor responders 2. Age >35 years

Exclusion Criteria

1. patient >44ys ,

2. AMH <0.3ng/ml,

3. FSH >13, also

4. patients of DM ,endometriosis ,general disease were excluded,

5. any local uterine anomalies were excluded.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

Kasr Alainy medical school

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

11

Identifier Type: -

Identifier Source: org_study_id