Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support

NCT ID: NCT01178931

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 853 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-12-31

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.)

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.

Conditions

Luteal Phase Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral dydrogesterone

Study group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week.

Group Type: ACTIVE_COMPARATOR

Oral dydrogesterone

Intervention Type: DRUG

oral-2x10mg

Crinone 8% vaginal gel

Control group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week.

Group Type: ACTIVE_COMPARATOR

Crinone 8% gel

Intervention Type: DRUG

vaginal-1x90mg

Interventions

Oral dydrogesterone

oral-2x10mg

Intervention Type: DRUG

Crinone 8% gel

vaginal-1x90mg

Intervention Type: DRUG

Other Intervention Names

Duphastone (Solvay Pharmaceuticals); Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Vlatka Tomic

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jozo Tomic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Human Reproduction, University Hospital Center Sisters of Mercy

Vlatka Tomic, M.D.

Role: STUDY_CHAIR

Department of Human Reproduction, University Hospital Center Sisters of Mercy

Locations

University Hospital Center Sisters of Mercy

Zagreb, , Croatia

Countries

Croatia

References

Tomic V, Tomic J, Klaic DZ, Kasum M, Kuna K. Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:49-53. doi: 10.1016/j.ejogrb.2014.11.002. Epub 2014 Nov 20.

Reference Type: DERIVED

PMID: 25622239 (View on PubMed)

Other Identifiers

KBSM-0010

Identifier Type: -

Identifier Source: org_study_id