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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT02333253

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Other Complications Associated With Artificial Fertilization	Drug: cetrotide	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: cetrotide 0.25 cetrotide S.c was added on when leading follicle reach >12 mm Other Names: cetrorelix acetate
Active Comparator: 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	Drug: cetrotide 0.25 cetrotide S.c was added on when leading follicle reach >12 mm Other Names: cetrorelix acetate

Arm

Intervention/Treatment

Active Comparator: 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

Drug: cetrotide

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

Other Names:

cetrorelix acetate

Active Comparator: 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

Drug: cetrotide

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

Other Names:

cetrorelix acetate

Outcome Measures

Primary Outcome Measures

oocyte retrieved number [Induction cycle an expected average of 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1 Poor responders 2. Age >35 years

Exclusion Criteria:

patient >44ys ,
AMH <0.3ng/ml,
FSH >13, also
patients of DM ,endometriosis ,general disease were excluded,
any local uterine anomalies were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12151

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ahmed M Maged, MD, Kasr Alainy medical school

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Maged, Assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT02333253

Other Study ID Numbers:

First Posted:

Jan 7, 2015

Last Update Posted:

Jan 27, 2016

Last Verified:

Jan 1, 2016

Keywords provided by Ahmed Maged, Assistant professor, Cairo University

poor responders

GnRH antagonist

Conventional protocol

Additional relevant MeSH terms:

Cetrorelix

Study Results

No Results Posted as of Jan 27, 2016