A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

PHASE3CompletedINTERVENTIONAL
Enrollment

1,070

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Female Infertility
Interventions
DRUG

Dydrogesterone 30 mg

Oral Dydrogesterone 10 mg tablets tid

DRUG

Micronized Progesterone 600 mg

Intravaginal micronized progesterone 200 mg capsules tid

DRUG

Placebo progesterone

Placebo intravaginal micronized progesterone 200 mg capsules tid

DRUG

Placebo dydrogesterone

placebo oral dydrogesterone 10 mg tablets tid

Trial Locations (40)

1070

Site reference no. 93598, Brussels

1090

Site reference no. 113176, Vienna

Site reference no. 93615, Brussels

1200

Site reference no. 93617, Brussels

2930

Site reference no. 93593, Brasschaat

3000

Site reference no. 93595, Leuven

3500

Site reference no. 93616, Hasselt

3600

Site reference no. 93613, Genk

7000

Site reference no. 93614, Mons

9000

Site reference no. 93594, Ghent

Site reference no. 93597, Ghent

10117

Site reference ID ORG-000645, Berlin

14050

Site reference ID ORG-000643, Berlin

20520

Site reference no. ORG-000633, Turku

23562

Site reference ID ORG-000883, Lübeck

28223

Site reference no. ORG-000640, Pozuelo de Alarcon (Madrid)

33100

Site reference ID ORG-000795, Tampere

38100

Research facility ID ORG-000934, Hadera

40100

Site reference ID ORG-000885, Jyväskylä

41011

Site reference no. ORG-000638, Seville

46015

Site reference no. ORG-000637, Valencia

48903

Site reference no. 119915, Baracaldo, Vizcaya

48940

Site reference no. ORG-000639, Bilbao

69120

Site reference ID ORG-000644, Heidelberg

69710

Site reference no. 93641, Tel Aviv

84101

Site reference no. 93635, Beersheba

90014

Site reference no. ORG-000635, Oulu

91120

Site reference no. 93638, Jerusalem

117036

FGBU Endocrinology Research Center of Minzdrav of Russia, Moscow

Moscow State Medical Dentistry University, Moscow

119192

"CJSC Nasledniki", Moscow

127473

Moscow State Medical Dentistry University, Moscow

191014

SBEIHPE - NWSMU n.a.l.l.Melnichko MoH and SD of RF, Saint Petersburg

192174

"St. Petersburg SBHI Maternity Hospital No 17 (main address)", Saint Petersburg

620028

"FSBI Ural SRI of Maternity and Child Protection of MoH and SD", Yekaterinburg

620043

Center of Family Medicine LC, Yekaterinburg

3339419

Research facility ID ORG-000935, Haifa

00180

Site reference ID ORG-000884, Helsinki

01307

Site reference ID ORG-000642, Dresden

08017

Site reference ID ORG-000791, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Abbott

INDUSTRY