Trial Outcomes & Findings for The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis. (NCT NCT01682642)

NCT ID: NCT01682642

Last Updated: 2015-03-20

Results Overview

number of MII cells retrieved

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2015-03-20

Participant Flow

Participant milestones

Measure	Zoladex After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.	Vaporization Only After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
Overall Study STARTED	61	59
Overall Study COMPLETED	61	58
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.

Baseline characteristics by cohort

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.33 years STANDARD_DEVIATION 3.63 • n=5 Participants	31.70 years STANDARD_DEVIATION 4.28 • n=7 Participants	31.02 years STANDARD_DEVIATION 3.96 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	61 participants n=5 Participants	58 participants n=7 Participants	119 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

number of MII cells retrieved

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Number of Metaphase II Cells (MII)	8.2 MII cells Standard Deviation 5.92	8.2 MII cells Standard Deviation 4.82

SECONDARY outcome

Timeframe: 12 weeks

The number of ongoing pregnancies obtained which still is the most important issue for the patients.

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Pregnancy Rate	39.3 percentage of ongoing pregnancies	39.7 percentage of ongoing pregnancies

SECONDARY outcome

Timeframe: 3 days after oocyte retrieval

The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Good Embryo Quality	59.3 percentage of good quality embryos	67.3 percentage of good quality embryos

SECONDARY outcome

Timeframe: 1 day after oocyte retrieval

number of 2PN

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Number of Pro Nuclear Cell (2PN)	5.4 number of pro nuclear cells Standard Deviation 4.03	5.6 number of pro nuclear cells Standard Deviation 4.20

SECONDARY outcome

Timeframe: 1 week after oocyte retrieval

number of blastocytes that can be cryopreserved

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Number of Cryopreserved Embryos	0.9 number of cryopreserved embryos Standard Deviation 1.40	1.6 number of cryopreserved embryos Standard Deviation 2.31

SECONDARY outcome

Timeframe: 3 weeks

total dose of FSH needed at the end of stimulation

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Total Follicle Stimulating Hormone (FSH) Dose	2561 IUs Standard Deviation 621.7	2303 IUs Standard Deviation 604.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

number of days needed before follicles in the ovary are mature for oocyte retrieval

Outcome measures

Measure	Zoladex n=61 Participants After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 Participants Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Number of Days of Stimulation	12.3 days Standard Deviation 1.86	11.3 days Standard Deviation 1.98

Adverse Events

Zoladex

Serious events: 11 serious events

Other events: 1 other events

Deaths: 0 deaths

Vaporization Only

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zoladex n=61 participants at risk After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 participants at risk Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Reproductive system and breast disorders OHSS	18.0% 11/61	12.1% 7/58

Other adverse events

Measure	Zoladex n=61 participants at risk After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment	Vaporization Only n=58 participants at risk Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Surgical and medical procedures miscarriage	1.6% 1/61 • Number of events 1	0.00% 0/58

Additional Information

dr. Wim Decleer, PI

Fertility Center AZ Jan Palfijn

Phone: 0032 9 325 92 20

Email: wim.decleer@janpalfijngent.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place