Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01178931
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Vlatka Tomic, University of Zagreb

Brief Summary:

The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.

(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)

Condition or disease Intervention/treatment Phase
Luteal Phase Defect Drug: Oral dydrogesterone Drug: Crinone 8% gel Not Applicable

Detailed Description:

The use of gonadotropin-releasing hormone (GnRH) agonists in the ovarian stimulation, which prevents a premature surge of luteal hormone (LH), ultimately leads to suppression of the pituitary gland and high levels of estrogen observed during induced cycles result in inhibiting effect on the implantation of human embryos.

The luteal support in in-vitro-fertilization (IVF) cycles can be prolonged using human chorion gonadotropin(hCG) and/or progesterone.

Since it has been noted that the use of hCG was related with higher risks of the onset of ovarian hyperstimulation syndrome (OHSS), progesterone is nowadays a product of choice in luteal support.

Currently vaginal progesterone is widely used, since the classic oral progesterone results in low bioavailability and lower pregnancy rate and the intramuscular progesterone (IM-P) daily injections are painful and may cause abscesses, inflammatory reactions and local soreness.

However, standard protocol for luteal phase support has not been established (i.e. optimal dosage, route or duration).

Dydrogesterone is a retroprogesterone with good oral bioavailability. Oral administration is clear advantage, due to expected higher patient compliance and better tolerability than currently used vaginal or IM-P.

We hypothesize that dydrogesterone has the same efficacy as vaginal progesterone but better tolerability due to less side effects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 853 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
Study Start Date : October 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Oral dydrogesterone
Study group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week.
Drug: Oral dydrogesterone
Other Name: Duphastone (Solvay Pharmaceuticals)

Active Comparator: Crinone 8% vaginal gel
Control group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week.
Drug: Crinone 8% gel
Other Name: Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)

Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks ]
    Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound.

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 10 weeks ]
    The side effects included the occurrence of headache, somnolence, nausea, abdominal pain, bloating, dizziness, headache, breast fullness, perineal irritation, vaginal discharge and bleeding, interference with coitus.

  2. Satisfaction [ Time Frame: 10 weeks ]
    Satisfaction score is determinate on the 5-point level scale with 1 being "absolutely satisfied" and 5 being "absolutely dissatisfied" and tolerability by yes and now answers regarding side effects that the supplements could cause.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • routine ovulation induction protocol with GnRH agonist
  • less than three prior IVF cycles
  • at least three aspirated oocytes
  • BMI <35 kg/m2
  • age <45 years

Exclusion Criteria:

  • history of dysfunctional uterine bleeding
  • acute urogenital disease
  • recurrent miscarriage
  • previous allergic reactions to a progesterone products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01178931

University Hospital Center Sisters of Mercy
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Principal Investigator: Jozo Tomic, M.D. Department of Human Reproduction, University Hospital Center Sisters of Mercy
Study Chair: Vlatka Tomic, M.D. Department of Human Reproduction, University Hospital Center Sisters of Mercy

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vlatka Tomic, MD, University of Zagreb Identifier: NCT01178931     History of Changes
Other Study ID Numbers: KBSM-0010
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Vlatka Tomic, University of Zagreb:
luteal phase support
oral progesterone
vaginal progesterone
pregnancy rate

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs