Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation.
OBJECTIVE
To assess the efficacy and safety of a vaginal progesterone (P(4)) insert (Endometrin) for luteal support for assisted reproductive technology (ART).


METHODS
Multicenter, randomized, open-label (assessor-blinded) phase III clinical trial.


METHODS
Twenty-five U.S. ART centers.


METHODS
A total of 1,211 ART patients randomized to three groups: Endometrin 100 mg twice daily (n = 404), Endometrin 100 mg three times daily (n = 404), and P(4) 90 mg 8% gel daily (n = 403).


METHODS
In vitro fertilization and ET were performed according to site-specific protocols. The day after oocyte retrieval, Endometrin or vaginal P(4) gel was begun for luteal support and continued for up to 10 weeks of pregnancy.


METHODS
Biochemical, clinical, and ongoing pregnancy and live birth rates.


RESULTS
Pregnancy rates were high and similar in all treatment groups, with biochemical rates exceeding 50%, clinical and ongoing rates >or=40%, and live birth rates at 35%-38%. The adverse event profiles were similar across groups.


CONCLUSIONS
Pregnancy rates and live birth rates for Endometrin (twice daily and three times daily) were high and similar to those for P(4) gel. The adverse event profiles for both were similar to that for P(4) gel and primarily due to IVF stimulation and oocyte retrieval. Endometrin was safe and well tolerated.
Doody
Kevin J
KJ
Center for Assisted Reproduction, Bedford, Texas, USA.
Schnell
Vicki L
VL
Foulk
Russell A
RA
Miller
Charles E
CE
Kolb
Bradford A
BA
Blake
Emily J
EJ
Yankov
Vladimir I
VI
D000293:Adolescent; D000328:Adult; D004338:Drug Combinations; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000009:adverse effects; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects; D008183:Luteal Phase / Q000187:drug effects*; D008596:Menotropins / Q000008:administration & dosage* / Q000009:adverse effects; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016037:Single-Blind Method; D016896:Treatment Outcome; D050477:Urofollitropin / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D004338:Drug Combinations; D005300:Fertility Agents, Female; D050477:Urofollitropin; D011374:Progesterone; D008596:Menotropins