Primary outcomeMean· June 2004-August 2010
Clinical Pregnancy Rate
| Group | Value (percentage) |
|---|---|
| Endometriosis, GnRH-a Treatment, IVF | 28.3 |
| Endometriosis, IVF | 25.4 |
| Tubal Infertility, IVF | 33.3 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataGnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.
NCTNCT01269125 (opens ClinicalTrials.gov in a new tab)Other id2003/89 PGNI
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 180 participants (actual)
- Sponsor
- University of Ioannina · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Greece
- Start
- May 2004
- Primary completion
- Aug 2010
- Completion
- Sept 2010
- First posted
- 4 Jan 2011 (estimated)
- Last update posted
- 30 Jul 2013 (estimated)
- Conditions
- Endometriosis · Infertility
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2004200620082010
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators attempted to establish a rationale for the Gonadotropin Releasing Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid and this action may improve the oocyte quality and the fertility of these women.
Interventions
- LeuprolideDrug
- IVFProcedure
Arms3
Active comparator
Endometriosis, leuprolide, IVF
Women with stage II endometriosis received GnRH-a (leuprolide) prior to an IVF attempt.
Active comparator
Endometriosis, IVF
Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
Active comparator
Tubal infertility, IVF
Women with tubal infertility underwent an IVF attempt.
Primary outcomes4
Outcomes the sponsor listed as primary.
Clinical Pregnancy Rate
Time frame · June 2004-August 2010
Registry description
Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.
Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).
Time frame · June 2004-August 2010
Registry description
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.
Fertilization Rate (Percentage of Fertilized Oocytes).
Time frame · June 2004-August 2010
Registry description
The fertilization rate was estimated for every woman 24 hours after oocyte retrieval
Clinical Pregnancy Rate
Time frame · 4 weeks after a positive pregnancy test
Registry description
Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.
Secondary outcomes(1)
Follicular Fluid's TNF-a Concentration.
Time frame · June 2004-August 2010
Registry description
TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· June 2004-August 2010
Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).
| Group | Value (Percentage of grade 1 embryos) |
|---|---|
| Endometriosis, GnRH-a Treatment, IVF | 25.5 |
| Endometriosis, IVF | 22.6 |
| Tubal Infertility, IVF | 27.0 |
Primary outcomeMean· June 2004-August 2010
Fertilization Rate (Percentage of Fertilized Oocytes).
| Group | Value (percentage) |
|---|---|
| Endometriosis, GnRH-a Treatment, IVF | 73.7 |
| Endometriosis, IVF | 62.7 |
| Tubal Infertility, IVF | 75.7 |
Primary outcomeMean· 4 weeks after a positive pregnancy test
Clinical Pregnancy Rate
| Group | Value (Percentage) |
|---|---|
| Endometriosis, GnRH-a Treatment, IVF | 28.3 |
| Endometriosis, IVF | 25.4 |
| Tubal Infertility, IVF | 33.3 |
Secondary and other outcome results(1)
Secondary outcomeMean· June 2004-August 2010
Follicular Fluid's TNF-a Concentration.
| Group | Value (pg/ml) | Spread |
|---|---|---|
| Endometriosis, GnRH-a Treatment, IVF | 21.4 | 6.7 |
| Endometriosis, IVF | 38.6 | 7.6 |
| Tubal Infertility, IVF | 22.5 | 5.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Endometriosis, GnRH-a Treatment, IVFWomen with mild endometriosis who received GnRH-a treatment prior to an IVF attempt. | – | 2 / 60 | 1 / 56 |
| Endometriosis, IVFWomen with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a. | – | 4 / 60 | 1 / 60 |
| Tubal Infertility, IVFWomen with tubal infertility underwent an IVF attempt. | – | 0 / 60 | 0 / 60 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 1999
5 results
A gonadotrophin-releasing hormone agonist compared with expectant management after conservative surgery for symptomatic endometriosis.
Vercellini et al. 1999British journal of obstetrics and gynaecologycited by 73
PMID 10428523DOI 10.1111/j.1471-0528.1999.tb08366.xPUB-10428523
Full text at the publisher5 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedKaponis A, Chatzopoulos G, Paschopoulos M, Georgiou I, Paraskevaidis V, Zikopoulos K, Tsiveriotis K, Taniguchi F, Adonakis G, Harada T. Ultralong administration of gonadotropin-releasing hormone agonists before in vitro fertilization improves fertilization rate but not clinical pregnancy rate in women with mild endometriosis: a prospective, randomized, controlled trial. Fertil Steril. 2020 Apr;113(4):828-835. doi: 10.1016/j.fertnstert.2019.12.018. Epub 2020 Mar 5. PMID 32147182
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 29 Years up to 38 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Infertility
* Mild endometriosis (until stage II)
Exclusion Criteria:
* ovarian endometrioma \> 2 cm
* FSH \> 12 mIU/ml
* Mail factor infertility
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