Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vlatka Tomic, University of Zagreb
ClinicalTrials.gov Identifier:
NCT01178931
First received: August 9, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention
Luteal Phase Defect
Drug: Oral dydrogesterone
Drug: Crinone 8% gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Number of participants with adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Satisfaction [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 853
Study Start Date: October 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
oral-2x10mg
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
vaginal-1x90mg
Other Name: Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178931

Locations
Croatia
University Hospital Center Sisters of Mercy
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Investigators
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
  More Information

No publications provided

Responsible Party: Vlatka Tomic, MD, University of Zagreb
ClinicalTrials.gov Identifier: NCT01178931     History of Changes
Other Study ID Numbers: KBSM-0010
Study First Received: August 9, 2010
Last Updated: January 27, 2014
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Zagreb:
IVF
luteal phase support
oral progesterone
vaginal progesterone
pregnancy rate
safety
tolerability

Additional relevant MeSH terms:
Dydrogesterone
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014