Trial Outcomes & Findings for GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles. (NCT NCT01269125)

Results Overview

Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

180 participants

Primary outcome timeframe

June 2004-August 2010

Results posted on

2013-07-30

Participant Flow

This prospective, randomized study with control group was carried out at the Department of Obstetrics and Gynecology, Ioannina University School of Medicine (Ioannina, Greece)during a 7-years period (May 2004 to September 2010).

Assessed for eligibility (n= 570) Excluded (n= 390) * Not meeting inclusion criteria (n= 102) * Declined to participate; underwent expectant management or IUI (n= 253) * Other reasons; lost to follow up (n=35)

Participant milestones

Participant milestones
Measure	Endometriosis, GnRH-a Treatment, IVF Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF Women with tubal infertility underwent an IVF attempt.
Overall Study STARTED	60	60	60
Overall Study COMPLETED	53	55	60
Overall Study NOT COMPLETED	7	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Endometriosis, GnRH-a Treatment, IVF Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF Women with tubal infertility underwent an IVF attempt.
Overall Study Adverse Event	3	5	0
Overall Study Lost to Follow-up	4	0	0

Baseline Characteristics

GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endometriosis, GnRH-a Treatment, IVF n=60 Participants Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=60 Participants Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 Participants Women with tubal infertility underwent an IVF attempt.	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=93 Participants	60 Participants n=4 Participants	60 Participants n=27 Participants	180 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	33.8 years STANDARD_DEVIATION 3.2 • n=93 Participants	31.8 years STANDARD_DEVIATION 2.1 • n=4 Participants	35.4 years STANDARD_DEVIATION 1.9 • n=27 Participants	33.6 years STANDARD_DEVIATION 2.4 • n=483 Participants
Sex: Female, Male Female	60 Participants n=93 Participants	60 Participants n=4 Participants	60 Participants n=27 Participants	180 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment Greece	60 participants n=93 Participants	60 participants n=4 Participants	60 participants n=27 Participants	180 participants n=483 Participants

PRIMARY outcome

Timeframe: June 2004-August 2010

Population: The study period was seven years. Practical issues such as, no more funds for measuring cytokines, my transportation to different University stopped this study before reaching adequate power. The flow of the participants in our Department was low.

Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.

Outcome measures

Outcome measures
Measure	Endometriosis, GnRH-a Treatment, IVF n=53 Participants Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=55 Participants Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 Participants Women with tubal infertility underwent an IVF attempt.
Clinical Pregnancy Rate	28.3 percentage Interval 17.0 to 43.0	25.4 percentage Interval 15.0 to 39.0	33.3 percentage Interval 17.0 to 41.0

PRIMARY outcome

Timeframe: June 2004-August 2010

Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with \< 10%, \< 10-20%, \< 20-30% and \>30% fragments were estimated as grade 1,2,3 and 4, respectively.

Outcome measures

Outcome measures
Measure	Endometriosis, GnRH-a Treatment, IVF n=53 Participants Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=55 Participants Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 Participants Women with tubal infertility underwent an IVF attempt.
Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).	25.5 Percentage of grade 1 embryos Interval 23.25 to 26.94	22.6 Percentage of grade 1 embryos Interval 20.21 to 33.85	27.0 Percentage of grade 1 embryos Interval 18.51 to 29.07

PRIMARY outcome

Timeframe: June 2004-August 2010

The fertilization rate was estimated for every woman 24 hours after oocyte retrieval

Outcome measures

Outcome measures
Measure	Endometriosis, GnRH-a Treatment, IVF n=53 Participants Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=55 Participants Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 Participants Women with tubal infertility underwent an IVF attempt.
Fertilization Rate (Percentage of Fertilized Oocytes).	73.7 percentage Interval 72.9 to 78.87	62.7 percentage Interval 57.03 to 66.08	75.7 percentage Interval 74.96 to 77.24

PRIMARY outcome

Timeframe: 4 weeks after a positive pregnancy test

Population: In order to handle the problem of small sample size bootstrap techniques are used. Ader et al recommend bootstrap procedures(a) distribution is complicated or unknown, (b) a small sample is available. Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.

Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.

Outcome measures

Outcome measures
Measure	Endometriosis, GnRH-a Treatment, IVF n=53 Participants Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=55 Participants Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 Participants Women with tubal infertility underwent an IVF attempt.
Clinical Pregnancy Rate	28.3 Percentage Interval 17.0 to 43.0	25.4 Percentage Interval 15.0 to 39.0	33.3 Percentage Interval 22.0 to 47.0

SECONDARY outcome

Timeframe: June 2004-August 2010

TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.

Outcome measures

Outcome measures
Measure	Endometriosis, GnRH-a Treatment, IVF n=53 Participants Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=55 Participants Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 Participants Women with tubal infertility underwent an IVF attempt.
Follicular Fluid's TNF-a Concentration. TNF-a	21.4 pg/ml Standard Deviation 6.7	38.6 pg/ml Standard Deviation 7.6	22.5 pg/ml Standard Deviation 5.4
Follicular Fluid's TNF-a Concentration. IL-1β	3.1 pg/ml Standard Deviation 1.1	9.3 pg/ml Standard Deviation 4	2.9 pg/ml Standard Deviation 0.8
Follicular Fluid's TNF-a Concentration. IL-6	16.7 pg/ml Standard Deviation 5.2	32.1 pg/ml Standard Deviation 6.5	14.7 pg/ml Standard Deviation 4.4
Follicular Fluid's TNF-a Concentration. IL-8	238.1 pg/ml Standard Deviation 66.4	347.8 pg/ml Standard Deviation 59.6	241 pg/ml Standard Deviation 46.7
Follicular Fluid's TNF-a Concentration. IL-1-ra	166.6 pg/ml Standard Deviation 42.6	183 pg/ml Standard Deviation 46	151.7 pg/ml Standard Deviation 39.6

Adverse Events

Endometriosis, GnRH-a Treatment, IVF

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Endometriosis, IVF

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Tubal Infertility, IVF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Endometriosis, GnRH-a Treatment, IVF n=56 participants at risk；n=60 participants at risk Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=60 participants at risk Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 participants at risk Women with tubal infertility underwent an IVF attempt.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	3.3% 2/60 • Number of events 2 • A 7-year period (2004-2010).	6.7% 4/60 • Number of events 4 • A 7-year period (2004-2010).	0.00% 0/60 • A 7-year period (2004-2010).

Other adverse events

Other adverse events
Measure	Endometriosis, GnRH-a Treatment, IVF n=56 participants at risk；n=60 participants at risk Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.	Endometriosis, IVF n=60 participants at risk Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.	Tubal Infertility, IVF n=60 participants at risk Women with tubal infertility underwent an IVF attempt.
Reproductive system and breast disorders Premature luteinization	1.8% 1/56 • Number of events 1 • A 7-year period (2004-2010).	1.7% 1/60 • Number of events 1 • A 7-year period (2004-2010).	0.00% 0/60 • A 7-year period (2004-2010).

Additional Information

Apostolos Kaponis, M.D.

Dept. of Ob/Gyn, Patra University School of Medicine, Greece

Phone: +30-2610999569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place