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

Other Complications Associated With Artificial Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333253
• Other study ID #: 11
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2015
• Last updated: January 26, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 44 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Other Complications Associated With Artificial Fertilization

Intervention

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

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	oocyte retrieved number		Induction cycle an expected average of 4 weeks	Yes