In Vitro FertilizationPhase 3NCT00827983

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

A Phase 3 study testing Progesterone in people with In Vitro Fertilization, run by IBSA Institut Biochimique SA at 14 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel). Read more about this study

Who is it for?: Ages 18 to 42 years, women only
Conditions the study is for: In Vitro Fertilization
What is being tested?: Progesterone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 683 participants
Where: 14 sitesin 5 countries
Study dates: Jan 2009to May 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 42 years
Women only
No healthy volunteers
Adult

Who may be able to join

Age 18- 42 (upon starting COH);
BMI <30 kg/m2;
<3 prior ART cycles (IVF, ICSI and related procedures);
Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
At least 3 retrieved oocytes;
Patient has given written informed consent.

Who cannot join

Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
Stage III or IV endometriosis (endometriomas);
Hydrosalpinx;
History of past poor response to COH resulting in canceling ART;
Use of thawed/donated oocytes;
Use of thawed/donated embryos;

Show all 19Show fewer

Patients affected by pathologies associated with any contraindication of being pregnant;
Hypersensitivity to study medication;
Uncontrolled adrenal or thyroid dysfunction;
Undiagnosed vaginal bleeding;
History of arterial disease;
Patients with hepatic impairment;
Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
High grade cervical dysplasia;
Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS;
Participation in a concurrent clinical trial or another trial within the past 2 months;
Use of concomitant medications that might interfere with the study evaluation;
Pre-implantation genetic diagnosis/screening.

Trial locations and contacts

14 sites in 5 countries.

Country

City, postcode or hospital

14 sites in 5 countries

Italy6 sites

Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico Brunico
Bruneck, Bolzano, 39031
Istituto Scientifico Universitario San Raffaele
Milan, Milan, 20132
Clinica Mangiagalli, Università di Milano
Milan, 20122
Azienda Ospedaliero-Sanitaria di Modena
Modena, 41100
Università degli Studi di Napoli 'Federico II
Naples, Naples, 80131
Ospedale Santa Chiara, Università degli studi di Pisa
Pisa, 56100

Other trials in Italy

United Kingdom4 sites

Midland Fertility Services
Aldridge, West Midlands, WS9 8LT
St. Bartholomew's Hospital - Center for Reproductive Medicine
London, EC1A 7BE
Guy's and St. Thomas' Hospital - Women's Health Department
London, SE1 9RT
The Bridge Center
London, SE1 9RY

Other trials in United Kingdom

Switzerland2 sites

Universitätsfrauenklinik Basel
Basel, 4031
IIRM SA
Sorengo, Canton Ticino, 6924

Other trials in Switzerland

Germany1 site

Klinik fur Frauenheilkunde und Geburthilfe - Universistät zu Lübeck
Lübeck, 23538

Other trials in Germany

Hungary1 site

First Dept. Obstetric and Gynaecology, Semmelweiss University Faculty of Medicine
Budapest, 1088

Other trials in Hungary

About this study

Official title: Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

Conditions: In Vitro Fertilization
Being tested: Progesterone
Keywords: Luteal Phase Support in IVF patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProgesteroneDrug
25 mg, s.c., once à day
ProgesteroneDrug
90 mg, vaginally, once à day

Study groups in NCT00827983
Study group	Role	What they receive
Progesterone SC	Experimental	Not described Receives: Drug: Progesterone
Progesterone Vaginal gel	Active comparator	Not described Receives: Drug: Progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

Ongoing Pregnancy Rate at the End of the Study
Measured: 10 weeks after treatment start

Secondary outcomes (2)

Delivery Rate and Live Birth Rate
Measured: nearly 9 month after treatment start
Implantation Rate
Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.
Measured: Four to five weeks after oocytes retrieval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009May 2011

First posted23 Jan 2009 (estimated)
Study startJan 2009
Primary completionNov 2010
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 683 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00827983
Sponsor's protocol ID: 07EU/Prg06
Status last verified: Jan 2013
First submitted: 22 Jan 2009
Last updated: 31 Jan 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Griesinger G, Trevisan S, Cometti B. Endometrial thickness on the day of embryo transfer is a poor predictor of IVF treatment outcome. Hum Reprod Open. 2018 Jan 29;2018(1):hox031. doi: 10.1093/hropen/hox031. eCollection 2018.
PubMed 30895243
Lockwood G, Griesinger G, Cometti B; 13 European Centers. Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study. Fertil Steril. 2014 Jan;101(1):112-119.e3. doi: 10.1016/j.fertnstert.2013.09.010. Epub 2013 Oct 17.
PubMed 24140033

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF

All In Vitro Fertilization trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
ClinicalTrials.gov ID: NCT00827983
Acronym / sponsor ID: 07EU/Prg06
Conditions: In Vitro Fertilization
Keywords: Luteal Phase Support in IVF patients
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 683 participants (actual)
Lead sponsor: IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Nov 2010 (actual)
Study completion: May 2011 (actual)
First posted: 23 Jan 2009 (estimated)
Results: Posted 26 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Progesterone SC	Experimental	Drug: Progesterone
Progesterone Vaginal gel	Active comparator	Drug: Progesterone

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Age 18- 42 (upon starting COH);
BMI <30 kg/m2;
<3 prior ART cycles (IVF, ICSI and related procedures);
Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);

Key exclusion criteria (19 listed)

Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
Stage III or IV endometriosis (endometriomas);
Hydrosalpinx;
History of past poor response to COH resulting in canceling ART;
Use of thawed/donated oocytes;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Progesterone25 mg, s.c., once à day	Drug	Progesterone SC
Progesterone90 mg, vaginally, once à day	Drug	Progesterone Vaginal gel

Primary outcome

Ongoing Pregnancy Rate at the End of the Study
Time frame: 10 weeks after treatment start

2 secondary outcomes

Delivery Rate and Live Birth Rate
Time frame: nearly 9 month after treatment start
Implantation Rate
Time frame: Four to five weeks after oocytes retrieval

Results and safety

Results posted to the registry on 26 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Progesterone SC	339	321
Progesterone Vaginal Gel	344	328

Primary outcome: Ongoing Pregnancy Rate at the End of the Study

Time frame: 10 weeks after treatment start. Number. Unit: percentage of randomized patient

Measure	Progesterone SC n = 339	Progesterone Vaginal Gel n = 344
Value	27.4	30.5

Progesterone SC vs Progesterone Vaginal Gel: Difference in pregnancy rates: -3.1 (95% CI -9.9 to 3.7), p = 0.37, Chi-squared

Population analysed: ITT population was analysed (i.e. all the randomised patients)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the 10 weeks of treatment, with a follow-up period of 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Progesterone SC	14 of 338 (4.1%)	168 of 338 (49.7%)	Not reported
Progesterone Vaginal Gel	20 of 344 (5.8%)	157 of 344 (45.6%)	Not reported

Limitations and caveats (from the sponsor): no special limitations of the trial were detected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30895243Griesinger G, Trevisan S, Cometti B. Endometrial thickness on the day of embryo transfer is a poor predictor of IVF treatment outcome. Hum Reprod Open. 2018 Jan 29;2018(1):hox031. doi: 10.1093/hropen/hox031. eCollection 2018.
Derived from this study: PubMed 24140033Lockwood G, Griesinger G, Cometti B; 13 European Centers. Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study. Fertil Steril. 2014 Jan;101(1):112-119.e3. doi: 10.1016/j.fertnstert.2013.09.010. Epub 2013 Oct 17.

Related trials for In Vitro Fertilization

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Progesterone in people with In Vitro Fertilization, run by IBSA Institut Biochimique SA at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy, United Kingdom, Switzerland, Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing Pregnancy Rate at the End of the Study (time frame: 10 weeks after treatment start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00827983, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.