Ignite Creation Date:
2024-05-06 @ 2:33 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02069808
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2014-02-19
Brief Title:
Efficacy of Recombinant FSHGnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation
Sponsor:
Michigan Reproductive Medicine
Organization:
Michigan Reproductive Medicine
Study Overview
Official Title:
Efficacy of Recombinant FSHGnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Disprove the null hypothesis as follows
Among the investigators egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below use of adjunctive LH activity medication Menopur will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur
Objectives
Compare efficacy of recombinant FSH Follistim with and without adjunct LH activity medication Menopur for our volunteer egg bank donors
Efficacy defined as
1 Days of ovarian stimulation to GnRH agonist trigger
2 Peak serum estradiol level on day of GnRH agonist trigger
3 Number of follicles 15 mm average diameter on day of GnRH agonist trigger
4 Number of mature oocytes recovered and cryopreserved
Study type Randomized prospective clinical trial
Patient selection Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank Age range 18-to 39 years BMI 18 to 25 Resting antral follicle count of 16 or greater Cycle day 3 FSH 10 mIUml AMH 20 ngml
Study design
Two groups- Group A- Recombinant FSH Follistim only Group B- Recombinant FSH Follistim and adjunct Menopur Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval
Random number generator with patients assigned basd on odd or even numbers
Number of subjects 25 in each group Total of 50 subjects This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study
Primary measure of outcome number of mature oocytes recovered and cryopreserved
Secondary measures of outcome
1 Days of ovarian stimulation to GnRH agonist trigger
2 Peak serum estradiol level on day of GnRH agonist trigger
3 Number of follicles 15 mm average diameter on day of GnRH agonist trigger
Among the investigators egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below use of adjunctive LH activity medication Menopur will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur
Objectives
Compare efficacy of recombinant FSH Follistim with and without adjunct LH activity medication Menopur for our volunteer egg bank donors
Efficacy defined as
1 Days of ovarian stimulation to GnRH agonist trigger
2 Peak serum estradiol level on day of GnRH agonist trigger
3 Number of follicles 15 mm average diameter on day of GnRH agonist trigger
4 Number of mature oocytes recovered and cryopreserved
Study type Randomized prospective clinical trial
Patient selection Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank Age range 18-to 39 years BMI 18 to 25 Resting antral follicle count of 16 or greater Cycle day 3 FSH 10 mIUml AMH 20 ngml
Study design
Two groups- Group A- Recombinant FSH Follistim only Group B- Recombinant FSH Follistim and adjunct Menopur Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval
Random number generator with patients assigned basd on odd or even numbers
Number of subjects 25 in each group Total of 50 subjects This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study
Primary measure of outcome number of mature oocytes recovered and cryopreserved
Secondary measures of outcome
1 Days of ovarian stimulation to GnRH agonist trigger
2 Peak serum estradiol level on day of GnRH agonist trigger
3 Number of follicles 15 mm average diameter on day of GnRH agonist trigger
Detailed Description:
Background
The investigators Center has been studying human oocyte cryopreservation by vitrification since July 1 2008 Western Institutional Board Review -WIRB Pro Nr 20081080 WIRB Study Nr 1100421 The first phase of the investigators study was to assess efficacy of oocyte cryopreservation among voluntary egg donors with end points for outcomes including rates of oocyte thaw survival fertilization embryo development implantation clinical pregnancy live birth and infant health The rationale for starting with egg donors was that they represent a population of women most likely to have optimal egg quality and a short turnaround time from vitrification to thaw IVF and embryo transfer into an appropriate egg recipient patient If the investigator could establish good outcomes when egg quality is optimal then there would be good hope to provide reliable egg cryopreservation technology to women in need of fertility preservation when facing treatment of cancer other illnesses for which treatments harm their eggs women choosing personal egg banking and for women who wish to avoid excess embryo creation on moral or religious grounds
The investigators study observations were that outcomes with use of previously cryopreserved donor eggs was equivalent to fresh donor eggs 90 of mature oocytes survived the thaw 76 of thawed oocytes fertilized normally with ICSI 98 of recipient women had a day 5 embryo transfer with one or two embryos transferred implantation rate of 42 60 or recipient women achieved clinical pregnancy 58 live birth rate and no birth defects have been observed in over 40 babies delivered through this technology at our Center
In the beginning of 2012 we opened up the second phase of the investigators study to include women in need of fertility preservation for the indications mentioned above No outcomes are yet known due to the expected time deferment from oocyte cryopreservation to use The favorable outcomes from donor egg bank IVF led to the investigators establishing the Michigan Egg Bank On October 22 2012 the American Society for Reproductive Medicine announced a new practice guideline that oocyte cryopreservation technology should be considered mainstream medical therapy and no long be considered experimental medical care The investigators closed the WIRB study November 26 2012
Rationale
Ovarian stimulation for egg donation should be provided offering the safest and simplest process for our egg donors Avoiding complications of ovarian hyperstimulation syndrome while assuring recruitment and harvest of good quality oocytes is a main goal in caring for the investigators volunteer egg donors Use of FSH medications with GnRH antagonist and GnRH agonist trigger is the protocol of choice for all of the investigators egg donors The investigators egg donors have experienced no complications and rapid recovery GnRH antagonists have been shown to suppress endogenous ovarian androgen synthesis In using GnRH antagonist adjunctive LH or low dose hCG combined with FSH medication has been a mainstream assumption to assure sufficient endogenous ovarian testosterone is present as a substrate for estrogen synthesis and normal folliculogenesis
In an effort to improve patient compliance by simplifying the use of medications for the investigators egg donors the investigator wishes to examine the efficacy of recombinant FSH without additional separate medication of adjunct LH activity in the form Menopur
The investigators Center has been studying human oocyte cryopreservation by vitrification since July 1 2008 Western Institutional Board Review -WIRB Pro Nr 20081080 WIRB Study Nr 1100421 The first phase of the investigators study was to assess efficacy of oocyte cryopreservation among voluntary egg donors with end points for outcomes including rates of oocyte thaw survival fertilization embryo development implantation clinical pregnancy live birth and infant health The rationale for starting with egg donors was that they represent a population of women most likely to have optimal egg quality and a short turnaround time from vitrification to thaw IVF and embryo transfer into an appropriate egg recipient patient If the investigator could establish good outcomes when egg quality is optimal then there would be good hope to provide reliable egg cryopreservation technology to women in need of fertility preservation when facing treatment of cancer other illnesses for which treatments harm their eggs women choosing personal egg banking and for women who wish to avoid excess embryo creation on moral or religious grounds
The investigators study observations were that outcomes with use of previously cryopreserved donor eggs was equivalent to fresh donor eggs 90 of mature oocytes survived the thaw 76 of thawed oocytes fertilized normally with ICSI 98 of recipient women had a day 5 embryo transfer with one or two embryos transferred implantation rate of 42 60 or recipient women achieved clinical pregnancy 58 live birth rate and no birth defects have been observed in over 40 babies delivered through this technology at our Center
In the beginning of 2012 we opened up the second phase of the investigators study to include women in need of fertility preservation for the indications mentioned above No outcomes are yet known due to the expected time deferment from oocyte cryopreservation to use The favorable outcomes from donor egg bank IVF led to the investigators establishing the Michigan Egg Bank On October 22 2012 the American Society for Reproductive Medicine announced a new practice guideline that oocyte cryopreservation technology should be considered mainstream medical therapy and no long be considered experimental medical care The investigators closed the WIRB study November 26 2012
Rationale
Ovarian stimulation for egg donation should be provided offering the safest and simplest process for our egg donors Avoiding complications of ovarian hyperstimulation syndrome while assuring recruitment and harvest of good quality oocytes is a main goal in caring for the investigators volunteer egg donors Use of FSH medications with GnRH antagonist and GnRH agonist trigger is the protocol of choice for all of the investigators egg donors The investigators egg donors have experienced no complications and rapid recovery GnRH antagonists have been shown to suppress endogenous ovarian androgen synthesis In using GnRH antagonist adjunctive LH or low dose hCG combined with FSH medication has been a mainstream assumption to assure sufficient endogenous ovarian testosterone is present as a substrate for estrogen synthesis and normal folliculogenesis
In an effort to improve patient compliance by simplifying the use of medications for the investigators egg donors the investigator wishes to examine the efficacy of recombinant FSH without additional separate medication of adjunct LH activity in the form Menopur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None