Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders
FOLLPRIM
Prospective Randomized Controlled Trial of Antral Follicle Priming Prior to IVF-ICSI in Previously Diagnosed Low Responders.
1 other identifier
interventional
66
1 country
1
Brief Summary
The aim of this study is to compare the effectiveness of testosterone,estradiol and a combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low responder patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 28, 2014
February 1, 2014
1.5 years
March 7, 2011
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of MII oocytes retrieved
36h after GnRH analogue administration
Secondary Outcomes (8)
Total number of follicles punctured
36h after GnRH analogue administration
Total number of oocytes retrieved
36h after GnRH analogue administration
Total number of viable embryos
48h after follicular puncture
Serum and Follicular hormonal levels (testosterone, androstenedione, estradiol)
36h after GnRH analogue administration
Granulosa cells genetic expression profile
36h after GnRH analogue administration
- +3 more secondary outcomes
Study Arms (3)
Testosterone
EXPERIMENTALTransdermal testosterone (20µg/day) from day 24 of the previous cycle until day 2 of the ICSI cycle
Estradiol
EXPERIMENTALTransdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle
CombEq
EXPERIMENTAL* (150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI * Estradiol valerate 4 mg/day during 10 days, starting the second day of the cycle prior to the ICSI cycle.
Interventions
Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle
Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle
(150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI. Valerate estradiol 4mg/day during 10 days, starting the second day of the cycle prios to the ICSI cycle.
Eligibility Criteria
You may qualify if:
- Phase 1 (Non randomized. The patient must fit the first plus at least other 2 criteria)
- Infertility requiring an IVF/ICSI treatment
- Age ≥ 38 years
- Basal FSH ≥ 10 mUI/ml (day 3 of the cycle)
- Serum AMH ≤ 5 pmol/l
- Antral follicular count ≤ 6 (day 3 of the cycle)
- Phase 2 (Randomized. The patient must fit at least one criterion regarding the day of GNRH analogue administration during the cycle performed in Phase 1)
- Less than 4 follicles which mean diameter measuring more than 16mm
- Serum estradiol levels ≤ 500 pg/ml
- MII or less than 4 MII oocytes retrieved
You may not qualify if:
- Patients suffering of endometriosis
- Patients having progesterone levels ≤ 4 ng/ml (day 21 of the cycle)
- Patients having a partner affected by severe oligo/astheno/teratozoospermia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
La Fe University Hospital. Department of Obstetrics and Gynecology
Valencia, 46026, Spain
Related Publications (3)
Fanchin R, Salomon L, Castelo-Branco A, Olivennes F, Frydman N, Frydman R. Luteal estradiol pre-treatment coordinates follicular growth during controlled ovarian hyperstimulation with GnRH antagonists. Hum Reprod. 2003 Dec;18(12):2698-703. doi: 10.1093/humrep/deg516.
PMID: 14645194BACKGROUNDFabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.
PMID: 19054777BACKGROUNDEscriva AM, Diaz-Garcia C, Monterde M, Rubio JM, Pellicer A. Antral Follicle Priming Before Intracytoplasmic Sperm Injection in Previously Diagnosed Low Responders: A Randomized Controlled Trial (FOLLPRIM). J Clin Endocrinol Metab. 2015 Jul;100(7):2597-605. doi: 10.1210/jc.2015-1194. Epub 2015 May 8.
PMID: 25955224DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
César Díaz, M.D.
La Fe University Hospital. Department of Obstetrics and Gynecology
- STUDY DIRECTOR
Antonio Pellicer, Professor
La Fe University Hospital. Department of Obstetrics and Gynecology
- STUDY CHAIR
Alicia Marzal, M.D.
La Fe University Hospital. Department of Obstetrics and Gynecology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 8, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2012
Study Completion
February 1, 2014
Last Updated
February 28, 2014
Record last verified: 2014-02